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

Recruiting
18 - 60 years of age
Both
Phase 4

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Overview

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?

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.

Eligibility

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 details

Obstructive Sleep Apnea of Adult

NCT06380491

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

30 April 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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