Clinical trial NCT06380491: Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)
Official title: Impact of Melatonin Treatment on Blood Pressure Circadian Rhythm, Sleep and Metabolic Variables.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obstructive Sleep Apnea of Adult
Keywords: Circadian Blood Pressure Rhythm
Obstructive sleep apnea
Melatonin
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
name: Emory University
First posted: 2024-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with a non-dipper pattern in blood pressure will randomly enter one of two options: 1) usual medical treatment; 2) treatment with melatonin plus usual care.
Primary purpose: TREATMENT

Brief 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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
Study officials:
affiliation: National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
name: Matilde Valencia-Flores, PhD
role: PRINCIPAL_INVESTIGATOR
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