P20 Extending Sleep to Reverse Metabolic Syndrome

November 13, 2024 updated by: NYU Langone Health

P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged Adults: Acceptability and Feasibility of a Sleep Intervention

This pilot study will test the acceptability and feasibility of a sleep extension intervention in community-dwelling, short-sleeping, racially/ethnically diverse middle-aged adults with MetS. Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pretest-posttest study design will test the efficacy of this 18-week study (2 weeks of baseline data collection, 1 week of study intervention planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of the 12-week intervention) on sleep duration, MetS risk behaviors (reduced physical activity, increased sedentary behavior, poor diet quality), symptoms associated with MetS risk behaviors (poor affective well-being, fatigue), and self-regulation. Socio-ecological barriers and facilitators to the intervention will be identified using a quantitative and qualitative approac

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

Screening and consent process. Potential participants will be informed about the study, provide verbal consent to be screened, and begin a multi-stage screening process consisting of a screening questionnaire (in person or by phone), an intake visit, and a home sleep test (OSA, sleep duration). The screening questionnaire will assess inclusion/exclusion criteria including demographics (NINR Demographic data), sleep duration and timing (STQ)70, insomnia symptoms (ISI), OSA symptoms (MAP), depressive symptoms (PROMIS depression v1.0), alcohol abuse (AUDIT), and self-reported habitual napping, sleep-promoting medication use, recent or planned shift work or trans-meridian travel, pregnancy/lactation, and current chemotherapy. Individuals meeting inclusion criteria based on the screening questionnaire will be invited to the CTSI visit. During the CTSI visit, the study team will describe the study and obtain written informed consent. MetS diagnosis will be confirmed based on measures of waist circumference, fasting glucose, serum triglycerides, high density lipoprotein cholesterol (HDL-c), and resting blood pressure. Waist circumference will assessed as the mean of 3 measurements taken at the level of the umbilicus using non-distensible measuring tape. Blood pressure will be assessed as the average of 3 recordings each taken 1 minute apart, following 10 minutes of inactivity. A 4th recording will occur if any two systolic or diastolic readings are >5 mmHg apart. Fasting glucose, serum triglycerides, and HDL-c will be measured from blood samples drawn according to standard venipuncture protocol at the CTSI. Analysis will be completed at the CTSI lab using standard techniques for analyzing the blood samples. Retained participants will be trained to use a home sleep apnea testing device (Embletta MPR) to objectively screen for OSA, a wrist accelerometer, and a sleep diary to screen for short sleep. Written instructions and study team contact information will be provided. Participants will return the home sleep apnea testing device in a prepaid package. Data will be downloaded from the home sleep apnea testing device and scored by a sleep technician to confirm the absence of moderate/severe OSA (AHI ≥15).

Baseline data collection. Retained participants will complete the remaining baseline measures for sleep duration, MetS risk behaviors (physical activity, sedentary behavior, diet quality, smoking, and alcohol use), sleep deprivation symptoms (quality of life/affective well-being, fatigue) and self-regulation. After baseline week 2, the study team will contact participants to remind them to return the accelerometer in the prepaid shipping package. Participants meeting all the inclusion criteria will be invited to participate in the intervention.

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.
44

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
    • New York
      • New York, New York, United States, 10010
        • New York University

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

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Greater than or equal to 35 years of age and less than or equal to 60 years of age. Middle aged adults have the highest prevalence of short sleep compared to other stages of adulthood.
  • Objectively confirmed MetS defined by three or more of the following: a) waist circumference greater than 120cm (men) or 88cm (women), b) blood pressure greater than or equal to 135 mmHg systolic or greater than or equal to 85 mmHg diastolic or antihypertensive medication use, c) fasting glucose greater than or equal to 110 mg/dL or insulin or oral hypoglycemic medication use, d) serum triglycerides greater than or equal to 150mg/dL or hypertriglyceride medication use, e) HDL-c less than 40mg/dL (women) or less than 50 mg/dL (men) or medication use for low HDL-c1. MetS was selected because individuals with MetS are at high risk for multiple chronic conditions.
  • Accelerometry confirmed short sleep (average work day sleep less than or equal to 6.5 hours/night). Self-reported sleep may overestimate sleep duration. This will ensure that participants will have short sleep patterns that are associated with MetS outcomes.
  • English speaking. Participants will need to demonstrate adequate English comprehension (assessed during informed consent).

Exclusion Criteria:

  • Pregnancy/lactation (self-reported). Pregnancy and lactation can disrupt habitual sleep patterns, and hormonal changes during pregnancy increase insulin resistance and may confound MetS.
  • Current chemotherapy treatments (self-reported). Current chemotherapy treatments may contribute to fatigue and sleep disturbances.
  • Alcohol abuse/dependence will be assessed with the Alcohol Use Disorders Identification Test (a measure that has demonstrated good reliability and validity). Alcohol abuse/dependence may contribute to sleep disturbances and limit the participant's ability to take part in sleep interventions.
  • Night shift or shift work (previous 2 months), trans-meridian travel (previous 4 weeks), or planned shift work or trans-meridian travel during intervention period (self-reported). These will be to ensure that sleep estimates from baseline represent participants' habitual sleep and to ensure adherence with the sleep intervention.
  • Moderate-severe or severe depression will be assessed with the PHQ-9. Moderate-severe depression or severe depression may contribute to sleep disturbances and interfere with the participant's ability to adhere to the sleep interventions.
  • Chronic use of sleep-promoting medications (self-reported). These may interfere with sleep patterns and limit the participant's ability to take part in the sleep interventions.
  • Habitual napping, defined as 2 naps per day or > 90 minutes of napping on 3 or more days of the week will be assessed during baseline with accelerometry. This will be to ensure adherence with the sleep intervention.
  • Diagnosed but untreated obstructive sleep apnea.

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: Short Sleep Patients
Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains >90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.
Behavioral: Sleep Intervention
  • Sleep Diaries (Daily)
  • Fitbit 24/7
  • Phone/ video conference calls (weekly with study team)
  • Epworth Sleepiness Scale (weekly)
  • PROMIS fatigue scale-evening (weekly)
Behavioral: Week 2 Intervention
  • Sleep Diaries (Daily)
  • Phone Calls (weekly with study team)
  • Wrist Accelerometry and fitbit 24/7 for 14 days
  • SAFTEE Questionnaire
  • ASA24
  • Behavioral risk factor surveillance system (smoking and alcohol use questions)
  • Psychological well-being (SF36)
  • Index of Self Regulation
  • PROMIS fatigue scale-morning (weekly)
  • PROMIS fatigue scale-evening (weekly)
  • Epworth Sleepiness Scale (weekly)

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
SASI Acceptability Questionnaire Score at Pre-Intervention
Time Frame: Baseline
14-item questionnaire assessing acceptability of SASI. Items are ranked on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is the average item score and ranges from 1-5. Higher total scores indicate greater overall acceptability.
Baseline
SASI Acceptability Questionnaire Score at Post-Intervention
Time Frame: Week 15
14-item questionnaire assessing acceptability of SASI. Items are ranked on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is the average item score and ranges from 1-5. Higher total scores indicate greater overall acceptability.
Week 15
Recruitment Rate
Time Frame: Baseline
The percentage of screened participants who were enrolled in the study.
Baseline
Retention Rate
Time Frame: Up to Week 15
Percentage of Enrolled Participants who completed the 15-Week intervention.
Up to Week 15
Protocol Adherence Rate
Time Frame: Week 15
The percentage of participants completing greater than or equal to 4 daily sleep diary entries per week for 80% or more of the intervention period.
Week 15

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
Change in Sleep Duration
Time Frame: Baseline, Week 15
Data estimated using wrist actigraph.
Baseline, Week 15
Change in SAFTEE Questionnaire Scores
Time Frame: Baseline, Week 15
128-item questionnaire asking participants to rank the level by which they have been bothered in the past week by common physical complaints people have, such as headaches, eye irritation, nasal congestion, etc. Items ranked on 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The total score is the average score of each item and ranges from 1-5; lower scores indicate less physical complaints. The change score is calculated as the change in scores between baseline and Week 15; the change score may range anywhere from 0-5.
Baseline, Week 15
Change in Physical Activity
Time Frame: Baseline, Week 15
Estimated using accelerometer (count of steps).
Baseline, Week 15
Change in Index of Self-Regulation (Sleep) Score
Time Frame: Baseline, Week 15
9-item questionnaire assessing self-regulation as it pertains to sleep. Items rated on 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). The total score is the average score for each item; higher scores indicate greater self-regulation.
Baseline, Week 15
Change in PROMIS Fatigue 6a Morning Score
Time Frame: Baseline, Week 15
6-item assessment of fatigue in the morning. Lowest score - 6; Highest score - 30; Lower score indicates less fatigue in the morning.
Baseline, Week 15
Change in PROMIS Fatigue 6a Evening Score
Time Frame: Baseline, Week 15
6-item assessment of fatigue in the Evening. Lowest score - 6; Highest score - 30; Lower score indicates less fatigue in the evening.
Baseline, Week 15

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.
NYU Langone Health

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: Susan Malone, MD, New York Langone Medical Center

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.
April 10, 2019

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.
June 4, 2021

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.
June 4, 2021

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).
July 12, 2018

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.
July 12, 2018

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.
July 24, 2018

Study Record Updates

Last Update Posted (Estimated)

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.
November 19, 2024

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.
November 13, 2024

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.
November 1, 2024

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.
  • 18-00707

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

The data will become available after all publications and presentations of the aims for this study are completed.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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