Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)
NCT ID: NCT06380491
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2023-06-22
2025-01-22
Brief Summary
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The main question it aims to answer is:
Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual care for nocturnal non-dipping Blood Pressurem in OSA
1\. Group of participants receives an intervention/treatment considered to be usual care
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.
Oral administration of 3 mg/day of melatonin for 30 days in non-dipping Blood Pressure in OSA
2\. Group of participants receives oral Melatonin 3 mg/day during 30 days plus usual care
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM):
Exclusion Criteria
* Use of Positive Airway Pressure (CPAP or Bipap)
* Neurologic or psychiatric disorder
18 Years
60 Years
ALL
No
Sponsors
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Universidad Nacional Autonoma de Mexico
OTHER
Emory University
OTHER
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
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Matilde Valencia-Flores
Coordinator/ Head of the Sleep Disorders Clinic
Principal Investigators
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Matilde Valencia-Flores, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
Locations
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National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
Mexico City, , Mexico
Countries
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Central Contacts
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References
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Other Identifiers
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UNAM-PAPIIT 32-IN216919
Identifier Type: OTHER
Identifier Source: secondary_id
REF.2338
Identifier Type: -
Identifier Source: org_study_id
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