NCT06380491

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

Impact of Melatonin Treatment on Blood Pressure Circadian Rhythm, Sleep and Metabolic Variables.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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?

Detailed description

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? Participants will: * Take melatonin or the habitual treatment every day for one month * Visit the clinic 11 times for one month * Keep a diary of their symptom and activities and use twice a 24 h ambulatory blood pressure monitoring (ABPM), attend two overnight polysomnography studies, and use an actigraph every day for 2 weeks. Researchers will compare melatonin to the habitual treatment to see if melatonin works to treat insomnia and recover the dipping blood pressure pattern. The medical problems that participants would have when taking melatonin are: * changes in blood pressure and cholesterol * Increased risk of contracting immune system disorders * Possible increased risk of liver damage.

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-06-22
• Primary completion: 2027-12-22
• Completion: 2028-01-22
• First posted: 2024-04-24
• Last updated: 2026-04-01

Locations

1 site across 1 country: Mexico