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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Sleep Patients | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| SASI Acceptability Questionnaire Score at Pre-Intervention | 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 | 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 | The percentage of screened participants who were enrolled in the study. | Baseline |
| Retention Rate | Percentage of Enrolled Participants who completed the 15-Week intervention. | Up to Week 15 |
| Protocol Adherence Rate | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Duration | Data estimated using wrist actigraph. | Baseline, Week 15 |
| Change in SAFTEE Questionnaire Scores | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Malone, MD | New York Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41528656 | Derived | Malone SK, Patterson F, Grunin L, Goyal C, Hu J, Perez NB, Munroe K, Dickson VV, Melkus GD. Single-arm pilot study of racial differences in sleep extension intervention outcomes among middle-aged adults at risk for metabolic syndrome. J Behav Med. 2026 Feb;49(1):79-89. doi: 10.1007/s10865-025-00624-4. Epub 2026 Jan 13. | |
| 40844144 |
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All of the individual participant data collected during the trial, after deidentification.
The data will become available after all publications and presentations of the aims for this study are completed.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Sleep Intervention: - Sleep Diaries (Daily)
Week 2 Intervention: - Sleep Diaries (Daily)
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Sleep Intervention: - Sleep Diaries (Daily)
Week 2 Intervention: - Sleep Diaries (Daily)
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SASI Acceptability Questionnaire Score at Pre-Intervention | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
15 Weeks
A systematic method was used for determining adverese events using a standrad questionnaire in the REDCAp databse (C-DASH). Participants were queried for adverse events weekly at the end of their intervention session.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Sleep Intervention: - Sleep Diaries (Daily)
Week 2 Intervention: - Sleep Diaries (Daily)
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor skin irritation on wrist while wearing the accelerometer. | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Malone, PhD, RN | NYU Langone Health | 212 992-7047 | Susan.Malone@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2022 | Nov 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D056128 | Obesity, Abdominal |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Week 2 Intervention | Behavioral |
|
|
| Baseline, Week 15 |
| Change in Physical Activity | Estimated using accelerometer (count of steps). | Baseline, Week 15 |
| Change in Index of Self-Regulation (Sleep) Score | 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 | 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 | 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 |
| Malone SK, Patterson F, Hu J, Goyal C, Goel N, Vaughan Dickson V, D'Eramo Melkus G, Aouizerat B. Association between dim light melatonin onset predicted from gene expression profiles with sleep time and chronotype preference: A pilot study. Chronobiol Int. 2025 Oct;42(10):1350-1359. doi: 10.1080/07420528.2025.2546006. Epub 2025 Aug 22. |
| 35067645 | Derived | Wright F, Malone SK, Wong A, D'Eramo Melkus G, Dickson VV. Addressing Challenges in Recruiting Diverse Populations for Research: Practical Experience From a P20 Center. Nurs Res. 2022 May-Jun 01;71(3):218-226. doi: 10.1097/NNR.0000000000000577. Epub 2022 Jan 24. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | SASI Acceptability Questionnaire Score at Post-Intervention | 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. | Posted | Mean | Standard Deviation | score on a scale | Week 15 |
|
|
|
| Primary | Recruitment Rate | The percentage of screened participants who were enrolled in the study. | Posted | Number | Percentage of participants | Baseline |
|
|
|
| Primary | Retention Rate | Percentage of Enrolled Participants who completed the 15-Week intervention. | Posted | Number | Percentage of participants | Up to Week 15 |
|
|
|
| Primary | Protocol Adherence Rate | 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. | Posted | Number | Percentage of participants | Week 15 |
|
|
|
| Secondary | Change in Sleep Duration | Data estimated using wrist actigraph. | Posted | Mean | Standard Deviation | hours | Baseline, Week 15 |
|
|
|
| Secondary | Change in SAFTEE Questionnaire Scores | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 15 |
|
|
|
| Secondary | Change in Physical Activity | Estimated using accelerometer (count of steps). | Posted | Mean | Standard Deviation | Step Counts | Baseline, Week 15 |
|
|
|
| Secondary | Change in Index of Self-Regulation (Sleep) Score | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 15 |
|
|
|
| Secondary | Change in PROMIS Fatigue 6a Morning Score | 6-item assessment of fatigue in the morning. Lowest score - 6; Highest score - 30; Lower score indicates less fatigue in the morning. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 15 |
|
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|
| Secondary | Change in PROMIS Fatigue 6a Evening Score | 6-item assessment of fatigue in the Evening. Lowest score - 6; Highest score - 30; Lower score indicates less fatigue in the evening. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 15 |
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| 0 |
| 44 |
| 0 |
| 44 |
| 4 |
| 44 |
| Finger Injury | General disorders | Systematic Assessment |
|
| Hospitalized for C-diff | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |