Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, 55, Brazil
NCT Number: NCT03567317
The purpose of this trial is to investigate the mechanisms leading to weight gain during CPAP treatment for obstructive sleep apnea (OSA).
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Notify Me50 year–80 year
All sexes
Interventional
Not applicable
São Paulo, 55, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Seven days
Extracellular fluid volume accumulation will be assessed by bioelectrical impedance after 7 days of CPAP or CPAP withdrawal.
Time frame: 24 hours
Basal metabolic rate will be assessed by indirect calorimetry after 7 days of CPAP or CPAP withdrawal.
Time frame: 7 days
Weight change during CPAP use
University of Sao Paulo General Hospital
Other
Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
Acronym: OSA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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