Melatonin's effects on sleep and blood pressure in patients with obstructive sleep apnea
Official title: Impact of Melatonin Treatment on Blood Pressure Circadian Rhythm, Sleep and Metabolic Variables.
Run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · NCT06380491 · Data updated 2026-11-12
This study tests if taking melatonin can help adults with obstructive sleep apnea sleep better and lower their blood pressure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Academic / other |
| Locations | 1 site (Mexico City) |
| Status | Recruiting |
| Started | June 22, 2023 |
| Main results expected | December 22, 2027 |
| Study ends | January 22, 2028 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT06380491 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults diagnosed with obstructive sleep apnea who experience insomnia and have a non-dipping blood pressure pattern.
✕Probably not a fit
Patients currently using sleep or psychiatric medications or those on CPAP or BiPAP therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of melatonin in treating insomnia and restoring normal blood pressure patterns in adults diagnosed with obstructive sleep apnea (OSA). Participants will take melatonin or their usual treatment daily for one month while attending multiple clinic visits. They will monitor their symptoms and activities, undergo blood pressure assessments, and participate in sleep studies to evaluate the impact of melatonin on their sleep quality and blood pressure regulation. The study aims to determine if melatonin can improve sleep maintenance and restore the dipping blood pressure pattern typically seen during sleep.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for improving sleep and blood pressure control in patients with obstructive sleep apnea.
How similar studies have gone: While the use of melatonin for sleep disorders is well-documented, this specific approach targeting blood pressure patterns in OSA patients is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Polisomnographic diagnosis of Obstructive Sleep Apnea * Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM): Exclusion Criteria: * Use of sleep or psychiatric medication * Use of Positive Airway Pressure (CPAP or Bipap) * Neurologic or psychiatric disorder
Where it's running
-
National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
Mexico City, Mexico Recruiting
Study contacts
- Principal investigator: Matilde Valencia-Flores, PhD — National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
- Study coordinator: Matilde Valencia-Flores, PhD
- Email: matilde.valenciaf@incmnsz.mx
- Phone: (+52 55) 54870900
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing whether smartwatches can help find signs of obstructive sleep apnea by tracking health data while you sleep.
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Training to strengthen breathing muscles in people with obstructive sleep apnea
This study is testing if a special breathing exercise program can help adults with obstructive sleep apnea feel less sleepy during the day and improve their breathing at night while using CPAP.
-
Oropharyngeal exercises for obstructive sleep apnea patients using a mandibular advancement device
This study is testing if special exercises for the throat and tongue can help adults with obstructive sleep apnea who are already using a mouth device to sleep better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.