Skip to main content
OpenTrials
Completed

NCT Number: NCT05253963

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 55, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure

Device

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

Primary outcomes

  1. Weight change

    Time frame: After 6 hours of Continuous Positive Airway Pressure treatment

    Weight change with just one night of CPAP treatment.

  2. Diuresis change

    Time frame: After 6 hours of Continuous Positive Airway Pressure treatment

    diuresis change with just one night of CPAP treatment.

Secondary outcomes

  1. Urinary osmolarity

    Time frame: After 10 hours of the nocturnal polysomnography

    Urine will be collected

  2. Atrial natriuretic peptide and antidiuretic hormone

    Time frame: After 10 hours of the nocturnal polysomnography

    Blood samples will be collected

  3. Intra and extracellular fluid volume

    Time frame: Before the beginning and after 10 hours of the nocturnal polysomnography.

    Intra and extracellular fluid volume accumulation will be assessed by bioelectrical impedance

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Acute Effect of Continuous Positive Airway Pressure (CPAP) on Weight in Patients With Previously Untreated Obstructive Sleep Apnea

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2022
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.