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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05253963
• Other study ID #: acuteweightgain
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: November 29, 2023

Study information

• Verified date: June 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: November 29, 2023
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Brazil	Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change	Weight change with just one night of CPAP treatment.	After 6 hours of Continuous Positive Airway Pressure treatment
Primary	Diuresis change	diuresis change with just one night of CPAP treatment.	After 6 hours of Continuous Positive Airway Pressure treatment
Secondary	Urinary osmolarity	Urine will be collected	After 10 hours of the nocturnal polysomnography
Secondary	Atrial natriuretic peptide and antidiuretic hormone	Blood samples will be collected	After 10 hours of the nocturnal polysomnography
Secondary	Intra and extracellular fluid volume	Intra and extracellular fluid volume accumulation will be assessed by bioelectrical impedance	Before the beginning and after 10 hours of the nocturnal polysomnography.