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

March 30, 2026 updated by: Matilde Valencia-Flores, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Usual care for nocturnal non-dipping Blood Pressurem in OSA
1. Group of participants receives an intervention/treatment considered to be usual care
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.
Other Names:
  • Usual Care for participants with OSA and nocturnal non-dipping Blood Pressure
Experimental: Oral administration of 3 mg/day of melatonin for 30 days in non-dipping Blood Pressure in OSA
2. Group of participants receives oral Melatonin 3 mg/day during 30 days plus usual care
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.
Other Names:
  • Usual Care for participants with OSA and nocturnal non-dipping Blood Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 30 days
Wake after sleep onset (WASO) and non-dipper patter of Blood Pressure change after melatonin intake for 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Collaborators

Emory University
Universidad Nacional Autonoma de Mexico

Investigators

  • Principal Investigator: Matilde Valencia-Flores, PhD, National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

December 22, 2027

Study Completion (Estimated)

January 22, 2028

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REF.2338
  • UNAM-PAPIIT 32-IN216919 (Other Identifier: Universidad Nacional Autonoma de Mexico (UNAM))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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