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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05253963

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: Continuous Positive Airway Pressure	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 29, 2021

Anticipated Primary Completion Date :

Sep 29, 2022

Anticipated Study Completion Date :

Sep 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control During the first and second study nights, subjects will undergo baseline polysomnography.
Experimental: Continuous Positive Airway Pressure 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 Continuous Positive Airway Pressure will be used during the second night of polysomnography .

Arm

Intervention/Treatment

No Intervention: Control

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

Experimental: Continuous Positive Airway Pressure

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

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

Outcome Measures

Primary Outcome Measures

Weight change [After 6 hours of Continuous Positive Airway Pressure treatment]
Weight change with just one night of CPAP treatment.
Diuresis change [After 6 hours of Continuous Positive Airway Pressure treatment]
diuresis change with just one night of CPAP treatment.

Secondary Outcome Measures

Urinary osmolarity [After 10 hours of the nocturnal polysomnography]
Urine will be collected
Atrial natriuretic peptide and antidiuretic hormone [After 10 hours of the nocturnal polysomnography]
Blood samples will be collected
Intra and extracellular fluid volume [Before the beginning and after 10 hours of the nocturnal polysomnography.]
Intra and extracellular fluid volume accumulation will be assessed by bioelectrical impedance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo	Sao Paulo		Brazil	55

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

Principal Investigator: Pedro R Genta, MD.PhD, Sleep Laboratoy, Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pedro Rodrigues Genta, Principal Investigator, University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT05253963

Other Study ID Numbers:

acuteweightgain

First Posted:

Feb 24, 2022

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pedro Rodrigues Genta, Principal Investigator, University of Sao Paulo General Hospital

Obstructive Sleep Apnea

Continuous Positive Airway Pressure

Weight Gain

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Study Results

No Results Posted as of Feb 24, 2022