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Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea (OSA)

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ClinicalTrials.gov Identifier: NCT03567317
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pedro Rodrigues Genta, University of Sao Paulo General Hospital

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

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: CPAP withdrawal Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: CPAP
According to study design, patients will be randomized to remain on CPAP during the initial study visit or withdraw CPAP one week before. If randomized to withdraw CPAP during the initial study visit, patients will resume CPAP use for one week before the second study visit.
Experimental: CPAP withdrawal
According to study design, patients will be randomized to remain on CPAP during the initial study visit or withdraw CPAP one week before. If randomized to withdraw CPAP at the second study visit, patients will withdraw CPAP one week before.
Device: CPAP withdrawal
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567317


Contacts
Contact: Pedro R Genta, MD 551126615486 prgenta@gmail.com

Locations
Brazil
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo Recruiting
Sao Paulo, Brazil, 55
Contact: Pedro R Genta, MD    551126625486    prgenta@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Pedro R Genta, MD Sleep Laboratoy, Heart Institute

Responsible Party: Pedro Rodrigues Genta, Principal Investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03567317     History of Changes
Other Study ID Numbers: weightgain
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pedro Rodrigues Genta, University of Sao Paulo General Hospital:
CPAP
Weight Gain
obstructive sleep apnea

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Weight Gain
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Body Weight Changes
Body Weight