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

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: Continuous Positive Airway Pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT05253963
acuteweightgain

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

38 participants in 2 patient groups

Control
No Intervention group
Description:
During the first and second study nights, subjects will undergo baseline polysomnography.
Continuous Positive Airway Pressure
Experimental group
Description:
Baseline polysomnography will be perfomed during the first study night and CPAP titration polysomnography will be performed during the second study night.
Treatment:
Device: Continuous Positive Airway Pressure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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