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Recruiting Phase 4

Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)

NCT06380491 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 4
Started
2023-06-22
Last updated
2026-04-01

Condition(s) studied

Obstructive Sleep Apnea of Adult

Investigational drug(s) / intervention(s)

Melatonin 3 MG Oral Tablet →

Melatonin 3 MG Oral Tablet: Participants with OSA and nocturnal non-dipping Blood Pressure will be randomly assigned to a treatment with melatonin 3mg/d or to receive only the usual care.

Study summary

The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.

The main question it aims to answer is:

Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure — 30 days
    Wake after sleep onset (WASO) and non-dipper patter of Blood Pressure change after melatonin intake for 30 days

Trial sites (1)

FacilityCityRegionStatus
National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) Mexico City Mexico Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06380491 on ClinicalTrials.gov ↗ ← All trials in Mexico