Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— OSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567317
• Other study ID #: weightgain
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
Brazil	Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extracellular fluid volume	Extracellular fluid volume accumulation will be assessed by bioelectrical impedance after 7 days of CPAP or CPAP withdrawal.	Seven days
Secondary	Basal metabolic rate	Basal metabolic rate will be assessed by indirect calorimetry after 7 days of CPAP or CPAP withdrawal.	24 hours
Secondary	Weight change	Weight change during CPAP use	7 days