Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380491
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-18
Brief Title:
Melatonins Effect on Nighttime Blood Pressure and Sleep in OSA Patients MEBP-OSA
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Overview
Official Title:
Impact of Melatonin Treatment on Blood Pressure Circadian Rhythm Sleep and Metabolic Variables
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEBP-OSA
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNAM-PAPIIT 32-IN216919 | OTHER | Universidad Nacional Autonoma de Mexico UNAM | None |