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NCT03588676
Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude
NA trial testing Melatonin in Intermittent Hypoxia in 39 participants. Completed in 10 December 2018.
10 December 2018
Quick facts
| Lead sponsor | Robert L. Owens |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 10 January 2018 |
| Primary completion | 10 December 2018 |
| Estimated completion | 10 December 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Melatonin (MELATONIN) — full drug profile →
- Placebo
Conditions studied
- Intermittent Hypoxia — all drugs for Intermittent Hypoxia →
Sponsor
Robert L. Owens
Who can join
Adults 18 to 65, any sex, with Intermittent Hypoxia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Low oxygen at altitude causes pauses in breathing during sleep, called central sleep apnea. Central sleep apnea causes repeated awakenings and poor sleep. Low oxygen itself and the induced oxidative stress can damage mental function which is likely worsened by poor sleep. Reduced mental function due to low oxygen can pose a serious danger to mountain climbers. However there is also mounting evidence that even in populations of people that live at high altitudes and are considered adapted, low oxygen contributes to reductions in learning and memory. Therefore there is a serious need for treatments which may improve sleep, control of breathing and mental function during low oxygen.Therefore this study aims to determine how melatonin effects control of breathing, sleep and mental performance during exposure to low oxygen.
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 NCT03588676
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Melatonin
Trials testing the same drug.
- NCT07221968 — Melatonin for the Treatment of DEE-SWAS · Phase 2 · not yet recruiting
- NCT07503600 — The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections · Phase 3 · not yet recruiting
- NCT07375342 — Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric · NA · enrolling by invitation
- NCT07305350 — EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES · Phase 2 · active not recruiting
- NCT07096635 — Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting
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 NCT03588676 (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 Robert L. Owens
- Last refreshed: 14 August 2019
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/NCT03588676.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing