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

NCT06380491 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-01

No results posted yet for this 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?

Conditions

  • Obstructive Sleep Apnea of Adult

Interventions

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.

Sponsors & Collaborators

  • Universidad Nacional Autonoma de Mexico

    collaborator OTHER
  • Emory University

    collaborator OTHER
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-22
Primary Completion
2027-12-22
Completion
2028-01-22

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06380491 on ClinicalTrials.gov