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

NCT05253963 | Completed

• 1 other identifier: acuteweightgain
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Continuous Positive Airway Pressure; Weight Gain

Outcome Measures

Primary Outcomes (2)

• Weight change

  Weight change with just one night of CPAP treatment.

  After 6 hours of Continuous Positive Airway Pressure treatment

• Diuresis change

  diuresis change with just one night of CPAP treatment.

  After 6 hours of Continuous Positive Airway Pressure treatment

Secondary Outcomes (3)

• Urinary osmolarity

  After 10 hours of the nocturnal polysomnography

• Atrial natriuretic peptide and antidiuretic hormone

  After 10 hours of the nocturnal polysomnography

• Intra and extracellular fluid volume

  Before the beginning and after 10 hours of the nocturnal polysomnography.

Study Arms (2)

Control

NO INTERVENTION

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

Continuous Positive Airway Pressure

EXPERIMENTAL

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

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure DEVICE

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

Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, 55, Brazil

Location

Related Publications (1)

• 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.

  PMID: 41025888 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Weight Gain

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Pedro R Genta, MD.PhD

  Sleep Laboratoy, Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: February 24, 2022
• Study Start: September 29, 2021
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

BR (1)