Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea (OSA)

Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea

The purpose of this trial is to investigate the mechanisms leading to weight gain during CPAP treatment for obstructive sleep apnea (OSA).

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: CPAP withdrawal

Detailed Description

Obesity and obstructive sleep apnea share a bidirectional relationship. While obesity is a major risk factor for OSA, OSA may contribute to weight gain. Recent evidence suggests that OSA treatment is associated with weight gain. The mechanisms involved in weight gain after OSA treatment are not known. The purpose of this study is to determine the mechanisms of weight gain during CPAP treatment for severe OSA leads. The investigators hypothesis is that CPAP leads to a decrease in energy expenditure and prevents the elimination of extracellular fluid that is accumulated during the day. In order to test this hypothesis, 20 patients with severe OSA aged between 50 and 80 years old, under regular treatment with CPAP, will be invited to participate. Using a cross-over design, the investigators will perform bioelectric impedance 5 times over 24 hours in order to assess the circadian effect of fluid accumulation in two different conditions: during CPAP treatment and 7 days after CPAP withdrawal. A full polysomnography will be performed during CPAP withdrawal to confirm severe OSA and during CPAP treatment to confirm adequate control of respiratory events. In addition, basal metabolic rate, hematocrit, serum BNP, urinary sodium, creatinine and osmolality will be determined in the morning during the CPAP and CPAP withdrawal periods.

• Study Type: Interventional
• Enrollment (Actual): 22
• 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: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with a diagnosis of severe OSA (AHI>30 events/h)
• 50 and 80 years old
• regular treatment with CPAP with an average daily use of >4hours

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: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CPAP; According to study design, patients will be randomized to remain on CPAP during the initial study visit or withdraw CPAP one week before. If randomized to withdraw CPAP during the initial study visit, patients will resume CPAP use for one week before the second study visit.
Experimental: CPAP withdrawal; According to study design, patients will be randomized to remain on CPAP during the initial study visit or withdraw CPAP one week before. If randomized to withdraw CPAP at the second study visit, patients will withdraw CPAP one week before.	Device: CPAP withdrawal; Patients randomized to withdrawal will stop CPAP use for one week before study evaluations. Patients will also undergo a polysomnography to confirm the presence of severe OSA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extracellular fluid volume	Extracellular fluid volume accumulation will be assessed by bioelectrical impedance after 7 days of CPAP or CPAP withdrawal.	Seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basal metabolic rate	Basal metabolic rate will be assessed by indirect calorimetry after 7 days of CPAP or CPAP withdrawal.	24 hours
Weight change	Weight change during CPAP use	7 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Herculano S, Grad GF, Drager LF, de Albuquerque ALP, Melo CM, Lorenzi-Filho G, Genta PR. Weight Gain Induced by Continuous Positive Airway Pressure in Patients with Obstructive Sleep Apnea Is Mediated by Fluid Accumulation: A Randomized Crossover Controlled Trial. Am J Respir Crit Care Med. 2021 Jan 1;203(1):134-136. doi: 10.1164/rccm.202005-1853LE.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; CPAP; Weight Gain
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Body Weight; Signs and Symptoms, Respiratory; Body Weight Changes; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Weight Gain
• Other Study ID Numbers: weightgain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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