Impact of Melatonin Treatment on Blood Pressure Circadian Rhythm, Sleep and Metabolic Variables.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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?
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• Polisomnographic diagnosis of Obstructive Sleep Apnea
• Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM):
Locations
Other Locations
Mexico
National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
RECRUITING
Mexico City
Contact Information
Primary
Matilde Valencia-Flores, PhD
matilde.valenciaf@incmnsz.mx
(+52 55) 54870900
Backup
Maria V Santiago, MSc
victoria.santiagoa@incmnsz.mx
(+52 55) 54870900
Time Frame
Start Date: 2023-06-22
Estimated Completion Date: 2025-01-22
Participants
Target number of participants: 50
Treatments
Experimental: Usual care for nocturnal non-dipping Blood Pressurem in OSA
1\. Group of participants receives an intervention/treatment considered to be usual care
Experimental: 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
Related Therapeutic Areas
Sponsors
Collaborators: Emory University, Universidad Nacional Autonoma de Mexico
Leads: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran