Mobile Sleep Intervention for OEF, OIF and OND Veterans

March 19, 2018 updated by: VA Office of Research and Development

Mobile Sleep and Pain Intervention for OEF, OIF and OND Veterans

Many Veterans of the recent wars in Iraq and Afghanistan struggle with chronic insomnia (trouble falling or staying asleep). Most current interventions for insomnia are time-consuming, making it difficult for this younger, working group of Veterans to use and benefit from these interventions. The investigators will assess whether Veterans find it helpful to use two health information technology tools, one for measuring participant sleep (the WatchPAT) and one for managing participant sleep (the CBTI Coach). The WatchPAT will measure physiological sleep in the Veteran participant's home. The CBTI Coach is a mobile health application used on the Veteran's mobile phone or tablet to teach skills that can reduce insomnia. The investigators will combine use of the WatchPAT with the CBTI Coach so Veterans can self-manage insomnia at home. Participants will record their physiological sleep and self-report on their sleep at home during a 6 week self-management program. The investigators will measure if Veterans find the tools helpful and easy to use, and which Veterans find the tools most helpful.

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

Sleep disturbance in the form of chronic insomnia (difficulty in falling or staying asleep) is a major health care problem for Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Chronic insomnia is often co-morbid with mental and behavioral health issues such as posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI), which are common in these Veterans. Current behavioral interventions like cognitive behavioral therapy for insomnia (CBTI) that are used to treat chronic insomnia are effective, but time-consuming. As a result, this largely younger, working cohort of Veterans does not use and benefit from these interventions as much as they could. The investigators will assess the usability and feasibility of two health information technology (HIT) tools for measuring objective and subjective sleep, and for self-managing chronic insomnia. An existing mobile sleep monitoring device used by some VA sleep clinics, the WatchPAT, will be used to measure objective sleep parameters in the Veteran's home. A benefit of this tool is that it can detect probable sleep apnea, which will permit referral of these Veterans for sleep apnea treatment instead of insomnia self-management. An existing VA mobile health application (or app), the CBTI Coach, can be used on a mobile device to teach skills to reduce insomnia based on the elements of manualized CBTI. The goal is to combine the WatchPAT and the CBTI Coach along with self-management guidance to help Veterans with chronic insomnia learn how to improve their sleep. As part of a 6-week pre-post intervention pilot usability and feasibility trial, patients will record their objective and subjective sleep at home at the beginning of the 6-week self-management trial and again at the end. Subjective sleep reports in the form of sleep diaries will be measured throughout the program as part of using the CBTI Coach app. The objective and subjective sleep reports will be combined and accessible from the mobile device and can be used to help guide sleep self-management by the participant. Self-management will be aided by self-management worksheets and features of the CBTI Coach App. Usability of the two HIT tools will be assessed within the conceptual framework of an Integrated Technology Acceptance Model via survey items about each of the HIT tools. Feasibility will be assessed using measures of the number of times that elements of the CBTI Coach were accessed during the 6-week program, and from a semi-structured qualitative interview conducted at the end of the program. In the interview, the investigators will obtain information about the barriers to and facilitators of use of the WatchPAT and CBTI Coach. If there is high use of these tools for insomnia self-management, then the pilot study will have provided important incremental value to the new VA CBTI Coach app. The investigators also will collect data about the user factors that impact use of the tools (e.g., depression, mild traumatic brain injury, age), and thereby either be able to target the tools toward those most likely to use them, or suggest further developments to increase use by potential users. The pilot sample will provide preliminary data on sleep outcomes. The proposed work is responsive to multiple priority areas for HSR&D including Healthcare Informatics, Healthcare Access, Mental and Behavioral Health, and Post-deployment Health. By partnering with the VA Office of Connected Health (Web and Mobile Solutions), the VA's eHealth QUERI, and the developers of the VA CBTI Coach App, the investigators will ensure that these findings are maximally useful for future versions of the CBTI Coach app. The investigators also will be able to determine the usefulness of an integrated mobile sleep assessment and self-management program that can be used by Veterans anywhere.

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.
38

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 Locations

  • United States
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must have served in the most recent wars in Iraq or Afghanistan (OIF, OEF or OND),
  • be age 21-65,
  • report current insomnia as defined by an Insomnia Index Severity 40 score > 10 5,79,
  • and report insomnia duration of at least 1 month and impaired daytime functioning (as measured by endorsing Much or Very Much on ISI Item 7 about how much sleep problems interfere with daily functioning).
  • In addition, eligible individuals must be willing to use a device provided by the study team (an iPod touch).

Exclusion Criteria:

  • Exclusions will include self-reported (or in-study determined) sleep apnea that is more than mild,
  • periodic leg movements,
  • or circadian rhythm disorder (delayed or advanced sleep phase).
  • Exclusions for WatchPAT use include use of alpha blockers or short-acting nitrates,
  • permanent pacemaker, or
  • sustained non-sinus cardiac arrhythmias. Sleep apnea will be assessed from the WatchPAT on the first night of objective sleep testing and participants excluded from further participation if apnea is documented.
  • Other exclusions include moderate to severe cognitive impairment defined by scores on the Telephone Mini Mental State Exam,
  • inability to speak and read English,
  • or malformation of the fingers that would preclude use of the WatchPAT device.
  • In addition, individuals meeting criteria for current active psychosis, mania, suicidal ideation with plan and intent, or excessive alcohol use as determined using the AUDIT-C will be excluded from participation.
  • Those with greater than mild sleep apnea as determined based on a WatchPAT-based Apnea-Hypopnea Index [AHI] > 15/hour of sleep, will be withdrawn from the study and referred for sleep apnea treatment.

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: Treatment
  • 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: WatchPAT and CBT-i Coach mobile app
Individuals use the WatchPAT sleep monitor and the CBT-i Coach app to self-manage insomnia
Device: WatchPAT sleep monitor
Self-management of insomnia using a mobile sleep device
Behavioral: CBT-i Coach mobile app
Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia

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
Number of Participants Using WatchPAT
Time Frame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
Use of WatchPAT on 3 nights. In Week 0 it is the number of participants who used the WatchPAT that Week (and participants had two possible nights during that week that they could use the WatchPAT). In Week 6 it is the number of participants who used the WatchPAT that Week (and participants had one night that they could use the WatchPAT). We measured participant adherence using a count of the number of participants who used the WatchPAT at Week 0, and the number of participants using the WatchPAT at Week 6.
Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
Number of Participants Using CBT-I Coach
Time Frame: Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)
CBT = Cognitive Behavioral Therapy. Use of CBT-I Coach sleep diaries in Week 0 and Week 6. We measured participant adherence by a count of the number of participants who used the CBT-I Coach at Week 0 (by our definition of use), and the number of participants using the CBT-I Coach at Week 6. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data.
Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)

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
Insomnia Severity Index Score
Time Frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Validated self-report measure of Insomnia Symptom Severity (ISI). The minimum ISI scale score is 0, the maximum scale score is 28, and higher scores indicate worse insomnia. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).
Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Pittsburgh Sleep Quality Index (PSQI) Total Score
Time Frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Validated self-report measure of self-reported sleep quality. The minimum PSQI Total scale score is 0, the maximum scale score is 21 and higher scale scores indicate worse subjective sleep quality. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).
Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Functional Outcomes of Sleep Score
Time Frame: Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)
Validated self-report short-form (10 item) measure of Functional Outcomes of Sleep-10 (FOSQ-10). The minimum FOSQ score is 5, the maximum score is 20, and higher scores indicate better functioning. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).
Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Rochester
Northeastern University

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: Karen S. Quigley, PhD, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
October 20, 2015

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.
November 16, 2016

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.
November 16, 2016

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).
February 12, 2015

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.
March 12, 2015

First Posted (Estimate)

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.
March 18, 2015

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.
April 20, 2018

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.
March 19, 2018

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.
March 1, 2018

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.
  • PPO 14-144

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

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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