Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)
- Conditions
- Obstructive Sleep Apnea of Adult
- Interventions
- Registration Number
- NCT06380491
- Lead Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Polisomnographic diagnosis of Obstructive Sleep Apnea
- Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM):
- Use of sleep or psychiatric medication
- Use of Positive Airway Pressure (CPAP or Bipap)
- Neurologic or psychiatric disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care for nocturnal non-dipping Blood Pressurem in OSA Melatonin 3 MG Oral Tablet 1. Group of participants receives an intervention/treatment considered to be usual care Oral administration of 3 mg/day of melatonin for 30 days in non-dipping Blood Pressure in OSA Melatonin 3 MG Oral Tablet 2. Group of participants receives oral Melatonin 3 mg/day during 30 days plus usual care
- Primary Outcome Measures
Name Time Method 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 30 days Wake after sleep onset (WASO) and non-dipper patter of Blood Pressure change after melatonin intake for 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
🇲🇽Mexico City, Mexico