Clinical trial NCT05253963: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Continuous Positive Airway Pressure
Weight Gain
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Weight change
timeFrame: After 6 hours of Continuous Positive Airway Pressure treatment
measure: Diuresis change
timeFrame: After 6 hours of Continuous Positive Airway Pressure treatment
Secondary outcomes:
measure: Urinary osmolarity
timeFrame: After 10 hours of the nocturnal polysomnography
measure: Atrial natriuretic peptide and antidiuretic hormone
timeFrame: After 10 hours of the nocturnal polysomnography
measure: Intra and extracellular fluid volume
timeFrame: Before the beginning and after 10 hours of the nocturnal polysomnography.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
Study officials:
affiliation: Sleep Laboratoy, Heart Institute
name: Pedro R Genta, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: