Obstructive Sleep Apnea of Adult
Conditions
Keywords
Circadian Blood Pressure Rhythm, Obstructive sleep apnea, Melatonin
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.
Interventions
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.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Universidad Nacional Autonoma de Mexico
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Contacts
CONTACTMatilde Valencia-Flores, PhD
CONTACTMaria V Santiago, MSc
PRINCIPAL_INVESTIGATORMatilde Valencia-Flores, PhD
National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
Outcome results
None listed