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

Acute Effect of Continuous Positive Airway Pressure (CPAP) on Weight in Patients With Previously Untreated Obstructive Sleep Apnea

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Continuous Positive Airway Pressure

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 55
    • Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; During the first and second study nights, subjects will undergo baseline polysomnography.
Experimental: 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.	Device: Continuous Positive Airway Pressure; Continuous Positive Airway Pressure will be used during the second night of polysomnography .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	Weight change with just one night of CPAP treatment.	After 6 hours of Continuous Positive Airway Pressure treatment
Diuresis change	diuresis change with just one night of CPAP treatment.	After 6 hours of Continuous Positive Airway Pressure treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Pedro R Genta, MD.PhD, Sleep Laboratoy, Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Obstructive Sleep Apnea; Weight Gain
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: acuteweightgain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No