search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Weight Gain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Continuous Positive Airway Pressure

Arm Description

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

Baseline polysomnography will be perfomed during the first study night and CPAP titration polysomnography will be performed during the second study night.

Outcomes

Primary Outcome Measures

Weight change
Weight change with just one night of CPAP treatment.
Diuresis change
diuresis change with just one night of CPAP treatment.

Secondary Outcome Measures

Urinary osmolarity
Urine will be collected
Atrial natriuretic peptide and antidiuretic hormone
Blood samples will be collected
Intra and extracellular fluid volume
Intra and extracellular fluid volume accumulation will be assessed by bioelectrical impedance

Full Information

First Posted
September 29, 2021
Last Updated
June 3, 2023
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05253963
Brief Title
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
Official Title
Acute Effect of Continuous Positive Airway Pressure (CPAP) on Weight in Patients With Previously Untreated Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
November 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Weight Gain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
During the first and second study nights, subjects will undergo baseline polysomnography.
Arm Title
Continuous Positive Airway Pressure
Arm Type
Experimental
Arm Description
Baseline polysomnography will be perfomed during the first study night and CPAP titration polysomnography will be performed during the second study night.
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Intervention Description
Continuous Positive Airway Pressure will be used during the second night of polysomnography .
Primary Outcome Measure Information:
Title
Weight change
Description
Weight change with just one night of CPAP treatment.
Time Frame
After 6 hours of Continuous Positive Airway Pressure treatment
Title
Diuresis change
Description
diuresis change with just one night of CPAP treatment.
Time Frame
After 6 hours of Continuous Positive Airway Pressure treatment
Secondary Outcome Measure Information:
Title
Urinary osmolarity
Description
Urine will be collected
Time Frame
After 10 hours of the nocturnal polysomnography
Title
Atrial natriuretic peptide and antidiuretic hormone
Description
Blood samples will be collected
Time Frame
After 10 hours of the nocturnal polysomnography
Title
Intra and extracellular fluid volume
Description
Intra and extracellular fluid volume accumulation will be assessed by bioelectrical impedance
Time Frame
Before the beginning and after 10 hours of the nocturnal polysomnography.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro R Genta, MD.PhD
Organizational Affiliation
Sleep Laboratoy, Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
55
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs