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

Last updated: March 30, 2026
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Overall Status: Active - Recruiting

Phase

4

Condition

Sleep Apnea Syndromes

Treatment

Melatonin 3 MG Oral Tablet

Clinical Study ID

NCT06380491
REF.2338
UNAM-PAPIIT 32-IN216919
  • Ages 18-60
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Polisomnographic diagnosis of Obstructive Sleep Apnea

  • Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM):

Exclusion

Exclusion Criteria:

  • Use of sleep or psychiatric medication

  • Use of Positive Airway Pressure (CPAP or Bipap)

  • Neurologic or psychiatric disorder

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Melatonin 3 MG Oral Tablet
Phase: 4
Study Start date:
June 22, 2023
Estimated Completion Date:
January 22, 2028

Study 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.

Connect with a study center

  • National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)

    Mexico City,
    Mexico

    Active - Recruiting

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