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
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this trial is to investigate the mechanisms leading to weight gain during CPAP treatment for obstructive sleep apnea (OSA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 3, 2020
April 1, 2020
1.3 years
June 11, 2018
April 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extracellular fluid volume
Extracellular fluid volume accumulation will be assessed by bioelectrical impedance after 7 days of CPAP or CPAP withdrawal.
Seven days
Secondary Outcomes (2)
Basal metabolic rate
24 hours
Weight change
7 days
Study Arms (2)
CPAP
NO INTERVENTIONAccording 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.
CPAP withdrawal
EXPERIMENTALAccording 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with a diagnosis of severe OSA (AHI\>30 events/h)
- and 80 years old
- regular treatment with CPAP with an average daily use of \>4hours
You may not qualify if:
- congestive heart failure
- renal insufficiency
- hepatic failure
- urinary incontinency
- diuretic therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, 55, Brazil
Related Publications (1)
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.
PMID: 32857590DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro R Genta, MD
Sleep Laboratoy, Heart Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 11, 2018
First Posted
June 25, 2018
Study Start
March 1, 2018
Primary Completion
July 1, 2019
Study Completion
December 1, 2019
Last Updated
April 3, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share