SleepSMART for Veterans With MCI and Insomnia (SleepSMART)

December 31, 2025 updated by: VA Office of Research and Development

Sleep-SMART for Veterans With MCI and Insomnia: A Pilot Study

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive Impairment (MCI). This study will develop and pilot test Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an adapted CBT-I treatment that incorporates Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) principles with a goal of improving sleep treatment and rehabilitation outcomes for Veterans with co-occurring MCI and insomnia. The innovation of this study centers on enhancing CBT-I by providing supportive cognitive strategies designed to improve treatment adherence, learning, and acceptability. The investigators anticipate that by improving sleep it can concurrently improve daily functioning, increase quality of life, prevent or reduce late-life disability, and mitigate long-term cognitive decline in this Veteran population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mild cognitive impairment (MCI) is an important public health concern for aging Veterans due to the increased risk for progression to dementia and increased mortality. Insomnia is common in MCI (occurring in up to 60% of patients) and increases risk for dementia, disability, and poor quality of life. Rates of MCI and insomnia are higher among Veterans than civilians, thus aging Veterans with MCI and comorbid insomnia represent a particularly high-risk population. The gold standard treatment for insomnia, Cognitive Behavioral Therapy for Insomnia (CBT-I), is a multi-component behavioral intervention. However, cognitive impairments experienced by individuals with MCI may limit the rate of progress in CBT-I. The use of memory support strategies can improve patient recall of therapeutic information, enhance treatment adherence, and improve treatment outcomes. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) provides compensatory strategies to improve learning, memory, attention, and executive functioning. CogSMART has been shown to improve cognition, functional capacity, neurobehavioral symptoms, and quality of life in diverse Veteran populations with cognitive impairment. Incorporating supportive CogSMART cognitive strategies into CBT-I has the potential to improve treatment learning, adherence, and outcomes for this Veteran population. This RR&D SPiRE research project will assist us in developing and evaluating Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an innovative user-informed approach for treatment of insomnia in Veterans with MCI. Sleep-SMART is intended to provide the core components of CBT-I along with training in compensatory cognitive strategies from CogSMART to enhance intervention adherence and learning. Provision of this supportive cognitive training will assist Veterans with cognitive impairments in maintaining compliance with the CBT-I regimen, thereby leading to faster and more complete treatment benefits. The principle aims for the investigation include: 1) developing the Sleep-SMART intervention and treatment manual; 2) assessing the feasibility and acceptability of Sleep-SMART in Veterans with MCI and insomnia; and 3) exploring the effects of Sleep-SMART on rehabilitation outcomes, quality of life, sleep, and cognitive functioning.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Veterans ages 60 or older who are competent to provide informed consent
  • Chart diagnosis of MCI based on previously published criteria
  • DSM-5 diagnosis of insomnia and an Insomnia Severity Index (ISI) score >7 at baseline
  • Ability to understand, speak, and read English with acceptable visual and auditory acuity

Exclusion Criteria:

  • Sleep disorders other than insomnia as determined by medical chart review and clinical interview
  • History of a neurological disorder, dementia, or moderate to severe TBI
  • Auditory, visual, or other impairments that would prevent ability to use video teleconferencing or participate in assessments
  • Schizophrenia, psychotic disorder, bipolar disorder, and/or current substance use disorder
  • Suicidality more than "low risk" as assessed by the Columbia Suicide Severity Rating Scale

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sleep-SMART
Sleep-SMART intervention
Behavioral: Sleep-SMART
Sleep-SMART is a telehealth delivered treatment for insomnia that follows the standard 6 session 50-minute Cognitive Behavioral Therapy for Insomnia (CBT-I) format. Sleep-SMART delivers CBT-I treatment along with training in select cognitive strategies from CogSMART to enhance intervention learning and adherence.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction. Mean scores were calculated at post-treatment. No statistical analyses were performed.
At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Telehealth Usability Questionnaire (TUQ)
Time Frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Scale to assess the usability of telehealth to deliver the intervention. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of the telehealth system, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the telehealth system.
At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Acceptability of Intervention Measure (AIM)
Time Frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Rating scale assessing intervention acceptability; scores range from 1-5 with higher scores indicating higher levels of acceptability. Ratings were collected at post-treatment. Mean scores were calculated. No statistical analyses were performed.
At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Intervention Appropriateness Measure (IAM)
Time Frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed.
At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: Immediately before and immediately after the intervention
Self-report scale assessing Subjective level of disability. Scores range from 0-100, where 0 = no disability; 100 = full disability.
Immediately before and immediately after the intervention
Independent Living Skills Survey (ILSS)
Time Frame: Immediately before and immediately after the intervention
Self-report scale assessing independent living skills; standardized scores ranging from 20 to 39 suggest maximum (full-time) supervision for daily living, scores from 40 to 49 suggest moderate supervision, and scores from 50 to 63 suggest minimum supervision, or independent living.
Immediately before and immediately after the intervention
Quality of Life Inventory (QOLI)
Time Frame: Immediately before and immediately after the intervention
Self-report scale assessing quality of life. Higher scores indicating better quality of life/satisfaction.
Immediately before and immediately after the intervention
Quality of Life in Neurological Disorders (Neuro-QOL) cognition scale
Time Frame: Immediately before and immediately after the intervention
Self-report scales assessing subjective cognitive complaints and subjective everyday functioning. Each response option is assigned a value (e.g., 1=Not at all). To find the total raw score, sum the values of the response to each question. For example, for an 8-item form that includes items with 5 response options ranging from 1 to 5, the lowest possible raw score is 8 (8 x 1) ; the highest possible raw score is 40 (8 x 5). Conversion tables are used to translate the total raw score into an IRT-based T score for each participant. A higher Neuro-QoL T-score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale.
Immediately before and immediately after the intervention
Everyday Cognition Scale (ECoG)
Time Frame: Immediately before and immediately after the intervention
Collateral measure of cognitive and everyday functioning. Is a 39 item questionnaire used to measure a patient's cognitive function and aid in the detection and diagnosis of dementia and other neurodegenerative diseases that are associated with aging. The final score is an average of the individual scores for each item answered out of the 39 items in the questionnaire and ranges from 1 to 4.
Immediately before and immediately after the intervention
Insomnia Severity Index (ISI)
Time Frame: Immediately before the intervention, weekly during the intervention, and immediately after the intervention
Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.
Immediately before the intervention, weekly during the intervention, and immediately after the intervention
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Immediately before and immediately after the intervention
Self-report scale assessing sleep quality over a 1-month interval. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper
Immediately before and immediately after the intervention
Hopkins Verbal Learning Test-Revised
Time Frame: Immediately before and immediately after the intervention
Performance based measure of verbal list learning and memory. Higher scores indicate better performance.
Immediately before and immediately after the intervention
Brief Visuospatial Memory Test-Revised
Time Frame: Immediately before and immediately after the intervention
Performance based measure of Visual design learning and memory. Scores are based on individual performance. Higher scores indicate better performance/memory.
Immediately before and immediately after the intervention
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span
Time Frame: Immediately before and immediately after the intervention
Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance.
Immediately before and immediately after the intervention
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test
Time Frame: Immediately before and immediately after the intervention
Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are converted to age-based scaled scores with higher scaled scores indicating better performance.
Immediately before and immediately after the intervention
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test
Time Frame: Immediately before and immediately after the intervention
Performance based measures of executive function. Scores are based on the number of words generated for the verbal fluency task. Raw scores are converted to age-based scaled scores with higher scaled scores indicating better performance.
Immediately before and immediately after the intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Self-report scale assessing Subjective level of disability. Scores range from 0-100, where 0 = no disability; 100 = full disability.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Quality of Life in Neurological Disorders (Neuro-QOL) Cognition Scale
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Self-report scales assessing subjective cognitive complaints and subjective everyday functioning. Each response option is assigned a value (e.g., 1=Not at all). To find the total raw score, sum the values of the response to each question. A higher Neuro-QoL score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Everyday Cognition Scale (ECoG)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Collateral measure of cognitive and everyday functioning. Is a 39 item questionnaire used to measure a patient's cognitive function and aid in the detection and diagnosis of dementia and other neurodegenerative diseases that are associated with aging. Each item is answered on a 1-4 point scale with a minimum total raw score of 39 and a maximum score of 156. Higher score are indicative of worse functioning.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Insomnia Severity Index (ISI)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The Global PSQI score ranges from 0 to 21 with higher scores indicating poorer sleep quality.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Brief Visuospatial Memory Test-Revised (Total Recall Raw Score)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0-36 with higher scores indicating better performance/memory.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test and range from <3 seconds to 240 seconds. Raw scores are presented in seconds with lower scores indicating better performance.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Performance based measures of executive function (i.e., category switching total raw score). The task requires participants to alternate between generating words from two different semantic categories. Scores are based on the number of correct words generated. Total raw scores range from 0 to >21, with higher scores indicating better performance.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Performance based measure of verbal list learning and memory (i.e., delayed recall raw score). Scores range from 0 to 12 with higher scores indicating better performance.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0 to 12. Higher scores indicate better performance/memory.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Performance based measure of verbal list learning and memory (i.e., immediate recall raw score). Scores range from 0 to 36 with higher scores indicating better performance.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are presented in seconds with lower scores indicating better performance.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing)
Time Frame: At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are presented in seconds with lower scores indicating better performance.
At pre-treatment and post-treatment. Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erin Almklov, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3721-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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