Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea

NCT ID: NCT05253963

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-29
• Study Completion Date: 2022-11-29

Brief Summary

The effect of CPAP on weight and fluid homeostasis will be assessed. Obstructive sleep apnea treatment-naive subjects will randomized to CPAP and control groups. Weight change, and changes in overnight urinary volume, intra and extracelullar volume, plasmatic B-type natriuretic peptide (BNP) and antidiuretic hormone (ADH) and urinary osmolality will be compared between groups.

Detailed Description

There is a bidirectional relationship between Obstructive Sleep Apnea (OSA) and obesity. Although obesity can lead to OSA, patients with OSA are more likely to gain weight. The mechanisms that lead to weight gain during the treatment of OSA are not known. Some evidence supports the hypothesis that fluid accumulation could be a possible explanation for weight gain after treatment for OSA. The hypothesis is that one night of CPAP treatment promotes increased body weight and reduced diuresis in patients with OSA. Participants will be submitted to 2 consecutive nights of polysomnography (PSG). A baseline PSG will be performed during the first study visit. During the second study night, participants will be randomized into two groups, CPAP and control (repeat baseline PSG). Overnight urinary volume will be determined. Intra and extracellular water volume will be assessed using electrical bioimpedance before bedtime and just after the subject wakes up. Plasmatic BNP and ADH and urinary osmolality will also be determined during each morning following PSG.

Conditions

Obstructive Sleep Apnea

Study Design

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

Study Groups

Control

During the first and second study nights, subjects will undergo baseline polysomnography.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Continuous Positive Airway Pressure

Baseline polysomnography will be perfomed during the first study night and CPAP titration polysomnography will be performed during the second study night.

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure

Intervention Type: DEVICE

Continuous Positive Airway Pressure will be used during the second night of polysomnography .

Interventions

Continuous Positive Airway Pressure

Continuous Positive Airway Pressure will be used during the second night of polysomnography .

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with a diagnosis of Obstructive Apnea Sleep
• Over 18 years of age
• No previous treatment with Continuous Positive Airway Pressure

Exclusion Criteria

• Congestive heart failure
• Renal insufficiency
• Hepatic failure
• Urinary incontinency
• Diuretic therapy

• Minimum Eligible Age: 18 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.PhD

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

Lima GF, Herculano S, Fernandes MD, Lima-Junior JGA, Alves RSC, Drager LF, Lorenzi-Filho G, Genta PR. Acute Effect of Continuous Positive Airway Pressure (CPAP) on Weight in Patients with Obstructive Sleep Apnea: A Randomized Study. Ann Am Thorac Soc. 2025 Sep 30. doi: 10.1513/AnnalsATS.202505-491OC. Online ahead of print.

Reference Type: DERIVED

PMID: 41025888 (View on PubMed)

Other Identifiers

acuteweightgain

Identifier Type: -

Identifier Source: org_study_id