Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea (OSA)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CPAP withdrawal
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring CPAP, Weight Gain, obstructive sleep apnea
Eligibility Criteria
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
Sites / Locations
- Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CPAP
CPAP withdrawal
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Extracellular fluid volume
Extracellular fluid volume accumulation will be assessed by bioelectrical impedance after 7 days of CPAP or CPAP withdrawal.
Secondary Outcome Measures
Basal metabolic rate
Basal metabolic rate will be assessed by indirect calorimetry after 7 days of CPAP or CPAP withdrawal.
Weight change
Weight change during CPAP use
Full Information
NCT ID
NCT03567317
First Posted
June 11, 2018
Last Updated
April 1, 2020
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03567317
Brief Title
Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea
Acronym
OSA
Official Title
Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to investigate the mechanisms leading to weight gain during CPAP treatment for obstructive sleep apnea (OSA).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
CPAP, Weight Gain, obstructive sleep apnea
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP
Arm Type
No Intervention
Arm Description
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.
Arm Title
CPAP withdrawal
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CPAP withdrawal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Extracellular fluid volume
Description
Extracellular fluid volume accumulation will be assessed by bioelectrical impedance after 7 days of CPAP or CPAP withdrawal.
Time Frame
Seven days
Secondary Outcome Measure Information:
Title
Basal metabolic rate
Description
Basal metabolic rate will be assessed by indirect calorimetry after 7 days of CPAP or CPAP withdrawal.
Time Frame
24 hours
Title
Weight change
Description
Weight change during CPAP use
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro R Genta, MD
Organizational Affiliation
Sleep Laboratoy, Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
55
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32857590
Citation
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. No abstract available.
Results Reference
derived
Learn more about this trial
Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea
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