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NCT Number: NCT06380491

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

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?

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Mexico City, Mexico

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 3 MG Oral Tablet

Drug

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria V Santiago, MSc

CONTACT

[email protected]

(+52 55) 54870900 ext. 3052

Matilde Valencia-Flores, PhD

CONTACT

[email protected]

(+52 55) 54870900 ext. 3056

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • Emory University
  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

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

Acronym: MEBP-OSA

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 24, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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