Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea (OSA)
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|ClinicalTrials.gov Identifier: NCT03567317|
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: CPAP withdrawal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||April 2020|
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.
- Extracellular fluid volume [ Time Frame: Seven days ]Extracellular fluid volume accumulation will be assessed by bioelectrical impedance after 7 days of CPAP or CPAP withdrawal.
- Basal metabolic rate [ Time Frame: 24 hours ]Basal metabolic rate will be assessed by indirect calorimetry after 7 days of CPAP or CPAP withdrawal.
- Weight change [ Time Frame: 7 days ]Weight change during CPAP use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567317
|Contact: Pedro R Genta, MDemail@example.com|
|Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo||Recruiting|
|Sao Paulo, Brazil, 55|
|Contact: Pedro R Genta, MD 551126625486 firstname.lastname@example.org|
|Principal Investigator:||Pedro R Genta, MD||Sleep Laboratoy, Heart Institute|