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

ConditionObstructive Sleep Apnea of Adult

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-60

SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Polisomnographic diagnosis of Obstructive Sleep Apnea

Disqualifiers

Use of sleep or psychiatric medication

Use of Positive Airway Pressure (CPAP or Bipap)

Neurologic or psychiatric disorder

Trial design

Design model

Parallel

Treatments tested in this trial

Melatonin 3 MG Oral Tablet
Drug
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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Usual care for nocturnal non-dipping Blood Pressurem in OSAExperimental treatment 1 intervention

Group B: Oral administration of 3 mg/day of melatonin for 30 days in non-dipping Blood Pressure in OSAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Wake after sleep onset (WASO) and non-dipper patter of Blood Pressure change after melatonin intake for 30 days

Time frame

30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Lead sponsor

Universidad Nacional Autonoma de Mexico

Collaborator

Emory University

Collaborator

Source ClinicalTrials.gov

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