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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05253963
Enrollment
38
Registered
2022-02-24
Start date
2021-09-29
Completion date
2022-11-29
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Weight Gain

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.

Interventions

DEVICEContinuous Positive Airway Pressure

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

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Weight changeAfter 6 hours of Continuous Positive Airway Pressure treatmentWeight change with just one night of CPAP treatment.
Diuresis changeAfter 6 hours of Continuous Positive Airway Pressure treatmentdiuresis change with just one night of CPAP treatment.

Secondary

MeasureTime frameDescription
Urinary osmolarityAfter 10 hours of the nocturnal polysomnographyUrine will be collected
Atrial natriuretic peptide and antidiuretic hormoneAfter 10 hours of the nocturnal polysomnographyBlood samples will be collected
Intra and extracellular fluid volumeBefore the beginning and after 10 hours of the nocturnal polysomnography.Intra and extracellular fluid volume accumulation will be assessed by bioelectrical impedance

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026