Metabolic SyndromeNCT03596983
P20 Extending Sleep to Reverse Metabolic Syndrome
A study testing Sleep Intervention and Week 2 Intervention in people with Metabolic Syndrome, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Sleep Intervention and Week 2 Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 4 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Sleep Intervention, Week 2 Intervention
- Keywords
- sleep intervention, metabolic syndrome, hypertension, type 2 diabetes, abdominal obesity, dyslipidemia
- Medical subject headings
- Metabolic Syndrome, Hypertension, Diabetes Mellitus, Type 2, Obesity, Abdominal, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep InterventionBehavioural
- Sleep Diaries (Daily)
- Fitbit 24/7
- Phone/ video conference calls (weekly with study team)
- Epworth Sleepiness Scale (weekly)
- PROMIS fatigue scale-evening (weekly)
Week 2 InterventionBehavioural
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Intervention; Behavioral: Week 2 Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 15
Recruitment Rate
The percentage of screened participants who were enrolled in the study.
Measured: Baseline
Retention Rate
Percentage of Enrolled Participants who completed the 15-Week intervention.
Measured: 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.
Measured: Week 15
Secondary outcomes (6)
Change in Sleep Duration
Data estimated using wrist actigraph.
Measured: 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.
Measured: Baseline, Week 15
Change in Physical Activity
Estimated using accelerometer (count of steps).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start10 Apr 2019
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Malone, MD, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596983
- Sponsor's protocol ID
- 18-00707
- Status last verified
- Nov 2024
- First submitted
- 12 Jul 2018
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
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.
PubMed 41528656Malone 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.
PubMed 40844144Wright 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.
PubMed 35067645
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged Adults: Acceptability and Feasibility of a Sleep Intervention
- ClinicalTrials.gov ID
- NCT03596983
- Acronym / sponsor ID
- 18-00707
- Conditions
- Metabolic Syndrome
- Keywords
- sleep intervention, metabolic syndrome, hypertension, type 2 diabetes, abdominal obesity, dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Posted 19 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short Sleep Patients | Experimental | Behavioral: Sleep Intervention, Behavioral: Week 2 InterventionIntervention: 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Short Sleep Patients |
| 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) | Behavioural | Short Sleep Patients |
Primary outcome
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.
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.
Recruitment Rate
Time frame: Baseline
The percentage of screened participants who were enrolled in the study.
Retention Rate
Time frame: Up to Week 15
Percentage of Enrolled Participants who completed the 15-Week intervention.
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.
6 secondary outcomes
Change in Sleep Duration
Time frame: Baseline, Week 15
Change in SAFTEE Questionnaire Scores
Time frame: Baseline, Week 15
Change in Physical Activity
Time frame: Baseline, Week 15
Change in Index of Self-Regulation (Sleep) Score
Time frame: Baseline, Week 15
Change in PROMIS Fatigue 6a Morning Score
Time frame: Baseline, Week 15
Change in PROMIS Fatigue 6a Evening Score
Time frame: Baseline, Week 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41528656Malone 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.
- Derived from this study: PubMed 40844144Malone 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.
- Derived from this study: PubMed 35067645Wright 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Malone, MD principal investigator
New York Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Intervention and Week 2 Intervention in people with Metabolic Syndrome, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SASI Acceptability Questionnaire Score at Pre-Intervention (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596983, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.