Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Continuous Positive Airway Pressure

• Registration Number: NCT05253963
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The effect of CPAP on weight and fluid homeostasis will be assessed. Obstructive sleep apnea treatment-naive subjects will randomized to CPAP and control groups. Weight change, and changes in overnight urinary volume, intra and extracelullar volume, plasmatic B-type natriuretic peptide (BNP) and antidiuretic hormone (ADH) and urinary osmolality will be compared between groups.

Detailed Description

There is a bidirectional relationship between Obstructive Sleep Apnea (OSA) and obesity. Although obesity can lead to OSA, patients with OSA are more likely to gain weight. The mechanisms that lead to weight gain during the treatment of OSA are not known. Some evidence supports the hypothesis that fluid accumulation could be a possible explanation for weight gain after treatment for OSA. The hypothesis is that one night of CPAP treatment promotes increased body weight and reduced diuresis in patients with OSA. Participants will be submitted to 2 consecutive nights of polysomnography (PSG). A baseline PSG will be performed during the first study visit. During the second study night, participants will be randomized into two groups, CPAP and control (repeat baseline PSG). Overnight urinary volume will be determined. Intra and extracellular water volume will be assessed using electrical bioimpedance before bedtime and just after the subject wakes up. Plasmatic BNP and ADH and urinary osmolality will also be determined during each morning following PSG.

Study Timeline

• Study Start: 2021-09-29
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-24
• Primary Completion: 2022-11-29
• Study Completion: 2022-11-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients with a diagnosis of Obstructive Apnea Sleep
• Over 18 years of age
• No previous treatment with Continuous Positive Airway Pressure

Exclusion Criteria

• Congestive heart failure
• Renal insufficiency
• Hepatic failure
• Urinary incontinency
• Diuretic therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Positive Airway Pressure	Continuous Positive Airway Pressure	Baseline polysomnography will be perfomed during the first study night and CPAP titration polysomnography will be performed during the second study night.

Primary Outcome Measures

Name	Time	Method
Weight change	After 6 hours of Continuous Positive Airway Pressure treatment	Weight change with just one night of CPAP treatment.
Diuresis change	After 6 hours of Continuous Positive Airway Pressure treatment	diuresis change with just one night of CPAP treatment.

Secondary Outcome Measures

Name	Time	Method
Intra and extracellular fluid volume	Before the beginning and after 10 hours of the nocturnal polysomnography.	Intra and extracellular fluid volume accumulation will be assessed by bioelectrical impedance
Urinary osmolarity	After 10 hours of the nocturnal polysomnography	Urine will be collected
Atrial natriuretic peptide and antidiuretic hormone	After 10 hours of the nocturnal polysomnography	Blood samples will be collected

Trial Locations

Locations (1)

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo; 🇧🇷 Sao Paulo, Brazil