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NCT03599388
Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention
NA trial testing Self- management for adequate sleep intervention (SASI) in Sleep in 14 participants. Completed in 2 April 2019.
2 April 2019
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 14 |
| Start date | 1 November 2018 |
| Primary completion | 2 April 2019 |
| Estimated completion | 2 April 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Self- management for adequate sleep intervention (SASI)
Conditions studied
- Sleep — all drugs for Sleep →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
Sponsor
NYU Langone Health — full company profile →
Who can join
Adults 40 to 60, any sex, with Sleep or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This pilot study will test acceptability and feasibility of a sleep extension intervention in community dwelling, short sleeping, racially/ethnically diverse middle aged adults with Metabolic Syndrome (METs). Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pre-test, post-test 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 planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of the 12 week intervention) on sleep duration, MetS factors (waist circumference, blood pressure, fasting glucose, trigycerides, HDL-c), 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 approach.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03599388
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other NYU Langone Health trials
Trials by the same sponsor.
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- NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
- NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
- NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03599388 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 15 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03599388.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing