Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea

NCT ID: NCT03567317

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-12-01

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

CPAP withdrawal

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pedro Rodrigues Genta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro R Genta, MD

Role: PRINCIPAL_INVESTIGATOR

Sleep Laboratoy, Heart Institute

Locations

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 32857590 (View on PubMed)

Other Identifiers

weightgain

Identifier Type: -

Identifier Source: org_study_id