Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Enrolling; Phase 4

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Drug: Melatonin 3 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06380491

UNAM-PAPIIT 32-IN216919 (Other Identifier)

REF.2338

Details and patient eligibility

About

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?

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Usual care for nocturnal non-dipping Blood Pressurem in OSA

Experimental group

Description:

1. Group of participants receives an intervention/treatment considered to be usual care

Treatment:

Drug: Melatonin 3 MG Oral Tablet

Oral administration of 3 mg/day of melatonin for 30 days in non-dipping Blood Pressure in OSA

Experimental group

Description:

2. Group of participants receives oral Melatonin 3 mg/day during 30 days plus usual care

Treatment:

Drug: Melatonin 3 MG Oral Tablet