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OpenTrials
Completed

NCT Number: NCT03567317

Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea

The purpose of this trial is to investigate the mechanisms leading to weight gain during CPAP treatment for obstructive sleep apnea (OSA).

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Key information

Age range

50 year–80 year

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

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.

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 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

Treatment and study plan

CPAP withdrawal

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.

Primary outcomes

  1. Extracellular fluid volume

    Time frame: Seven days

    Extracellular fluid volume accumulation will be assessed by bioelectrical impedance after 7 days of CPAP or CPAP withdrawal.

Secondary outcomes

  1. Basal metabolic rate

    Time frame: 24 hours

    Basal metabolic rate will be assessed by indirect calorimetry after 7 days of CPAP or CPAP withdrawal.

  2. Weight change

    Time frame: 7 days

    Weight change during CPAP use

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea

Acronym: OSA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2018
Registry last updated
Apr 3, 2020

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.

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