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P20 Extending Sleep to Reverse Metabolic Syndrome
NA trial testing Sleep Intervention in Metabolic Syndrome in 44 participants. Completed in 4 June 2021.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 44 |
| Start date | 10 April 2019 |
| Primary completion | 4 June 2021 |
| Estimated completion | 4 June 2021 |
| Sites | 1 location across United States |
NYU Langone Health — full company profile →
Adults 35 to 60, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | 3.91 | ± 0.37 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | 4.3 | ± 0.37 |
The percentage of screened participants who were enrolled in the study.
| Group | Value | 95% CI |
|---|---|---|
| Screened Participants | 54 |
Percentage of Enrolled Participants who completed the 15-Week intervention.
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | 93 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | 99 |
Data estimated using wrist actigraph.
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | 1.11 | ± 1.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | 0.09 | ± 0.17 |
Estimated using accelerometer (count of steps).
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | -3576.17 | ± 16,620.33 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | -0.16 | ± 0.61 |
6-item assessment of fatigue in the morning. Lowest score - 6; Highest score - 30; Lower score indicates less fatigue in the morning.
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | 4.95 | ± 5.3 |
6-item assessment of fatigue in the Evening. Lowest score - 6; Highest score - 30; Lower score indicates less fatigue in the evening.
| Group | Value | 95% CI |
|---|---|---|
| Short Sleep Patients | 5.36 | ± 5.3 |
Time frame: 15 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Short Sleep Patients |
|---|---|---|
| Minor skin irritation on wrist while wearing the accelerometer. | General disorders | — |
| Finger Injury | General disorders | — |
| Hospitalized for C-diff | Gastrointestinal disorders | — |
Data from ClinicalTrials.gov NCT03596983 adverse events section.
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
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing