Melatonin's effects on sleep and blood pressure in patients with obstructive sleep apnea
Impact of Melatonin Treatment on Blood Pressure Circadian Rhythm, Sleep and Metabolic Variables.
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Academic / other |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06380491 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with obstructive sleep apnea who experience insomnia and have a non-dipping blood pressure pattern.
Not a fit: Patients currently using sleep or psychiatric medications or those on CPAP or BiPAP therapy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mexico City
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.