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NCT04286451: SLEEP-IN
Effect of Sleep Restriction on Adipose Tissue and Skeletal Muscle Insulin Sensitivity
NA trial testing Sleep Restriction in Sleep Disturbance in 14 participants. Completed in 13 April 2022.
13 April 2022
Quick facts
| Lead sponsor | Pennington Biomedical Research Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 14 |
| Start date | 28 July 2020 |
| Primary completion | 13 April 2022 |
| Estimated completion | 13 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sleep Restriction
- Habitual Sleep
Conditions studied
- Sleep Disturbance — all drugs for Sleep Disturbance →
- Postmenopausal Symptoms — all drugs for Postmenopausal Symptoms →
- Insulin Sensitivity — all drugs for Insulin Sensitivity →
- Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
Sponsor
Pennington Biomedical Research Center — full company profile →
Who can join
Eligibility, female only, with Sleep Disturbance or Postmenopausal Symptoms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Inadequate sleep is an independent risk factor for metabolic abnormalities (such as obesity, insulin resistance, and hyperglycemia). Women report sleep disruption during the menopause transition (perimenopause) and into the postmenopausal years. Sleep disruption is one of the primary reasons why midlife women seek medical care, with up to 60% reporting significant sleep disturbances (e.g., trouble falling asleep, early morning waking, and hot flashes/night sweats). Despite the majority of women experiencing sleep disruption, no study has investigated the molecular mechanisms linking sleep disruption and the changes in metabolism that coincide with menopause.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of sleep restriction on insulin sensitivity and energy metabolism in postmenopausal women: A randomized crossover trial.
Singh P, Beyl RA, Stephens JM, Noland RC, et al · · 2023 · cited 10× · PMID 36998155 · DOI 10.1002/oby.23739 -
Shortened sleep duration impairs adipose tissue adrenergic stimulation of lipolysis in postmenopausal women.
Singh P, Beyl RA, Stephens JM, Richard AJ, et al · · 2024 · cited 1× · PMID 39462901 · DOI 10.1002/oby.24162 -
Transcriptional remodeling of human skeletal muscle following sleep restriction in postmenopausal women.
Suryadevara HNSK, Hebert RC, Staszkiewicz J, Ravussin E, et al · · 2026 · PMID 41902670 · DOI 10.1152/physiolgenomics.00269.2025
Verify or expand the search:
- PubMed search for NCT04286451
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Currently open trials in the same condition.
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Other Pennington Biomedical Research Center trials
Trials by the same sponsor.
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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 NCT04286451 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pennington Biomedical Research Center
- Last refreshed: 16 November 2022
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/NCT04286451.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing