Obstructive Sleep ApneaNCT05253963
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
A study testing Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Sep 2021to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of Obstructive Apnea Sleep
- Over 18 years of age
- No previous treatment with Continuous Positive Airway Pressure
Who cannot join
- Congestive heart failure
- Renal insufficiency
- Hepatic failure
- Urinary incontinency
- Diuretic therapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, 55
About this study
Official title: Acute Effect of Continuous Positive Airway Pressure (CPAP) on Weight in Patients With Previously Untreated Obstructive Sleep Apnea
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Weight Gain
- Medical subject headings
- Sleep Apnea, Obstructive, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Continuous Positive Airway Pressure will be used during the second night of polysomnography .
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | During the first and second study nights, subjects will undergo baseline polysomnography. |
| Continuous Positive Airway Pressure | Experimental | Baseline polysomnography will be perfomed during the first study night and CPAP titration polysomnography will be performed during the second study night. Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight change with just one night of CPAP treatment.
Measured: After 6 hours of Continuous Positive Airway Pressure treatment
Diuresis change
diuresis change with just one night of CPAP treatment.
Measured: After 6 hours of Continuous Positive Airway Pressure treatment
Secondary outcomes (3)
Urinary osmolarity
Urine will be collected
Measured: After 10 hours of the nocturnal polysomnography
Atrial natriuretic peptide and antidiuretic hormone
Blood samples will be collected
Measured: After 10 hours of the nocturnal polysomnography
Intra and extracellular fluid volume
Intra and extracellular fluid volume accumulation will be assessed by bioelectrical impedance
Measured: Before the beginning and after 10 hours of the nocturnal polysomnography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start29 Sep 2021
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Rodrigues Genta, University of Sao Paulo General Hospital
- Investigators
- Pedro R Genta, MD.PhD, Principal investigator, Sleep Laboratoy, Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253963
- Sponsor's protocol ID
- acuteweightgain
- Status last verified
- May 2024
- First submitted
- 29 Sep 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lima GF, Herculano S, Fernandes MD, Lima-Junior JGA, Alves RSC, Drager LF, Lorenzi-Filho G, Genta PR. Acute effect of continuous positive airway pressure on weight in patients with obstructive sleep apnea: a randomized study. Ann Am Thorac Soc. 2026 Mar 1;23(3):429-437. doi: 10.1513/AnnalsATS.202505-491OC.
PubMed 41025888
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Continuous Positive Airway Pressure (CPAP) on Weight in Patients With Previously Untreated Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05253963
- Acronym / sponsor ID
- acuteweightgain
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –During the first and second study nights, subjects will undergo baseline polysomnography. |
| Continuous Positive Airway Pressure | Experimental | Device: Continuous Positive Airway PressureBaseline polysomnography will be perfomed during the first study night and CPAP titration polysomnography will be performed during the second study night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of Obstructive Apnea Sleep
- Over 18 years of age
- No previous treatment with Continuous Positive Airway Pressure
Key exclusion criteria (5 listed)
- Congestive heart failure
- Renal insufficiency
- Hepatic failure
- Urinary incontinency
- Diuretic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureContinuous Positive Airway Pressure will be used during the second night of polysomnography . | Device | Continuous Positive Airway Pressure |
Primary outcome
Weight change
Time frame: After 6 hours of Continuous Positive Airway Pressure treatment
Weight change with just one night of CPAP treatment.
Diuresis change
Time frame: After 6 hours of Continuous Positive Airway Pressure treatment
diuresis change with just one night of CPAP treatment.
3 secondary outcomes
Urinary osmolarity
Time frame: After 10 hours of the nocturnal polysomnography
Atrial natriuretic peptide and antidiuretic hormone
Time frame: After 10 hours of the nocturnal polysomnography
Intra and extracellular fluid volume
Time frame: Before the beginning and after 10 hours of the nocturnal polysomnography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 41025888Lima GF, Herculano S, Fernandes MD, Lima-Junior JGA, Alves RSC, Drager LF, Lorenzi-Filho G, Genta PR. Acute effect of continuous positive airway pressure on weight in patients with obstructive sleep apnea: a randomized study. Ann Am Thorac Soc. 2026 Mar 1;23(3):429-437. doi: 10.1513/AnnalsATS.202505-491OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro R Genta, MD.PhD principal investigator
Sleep Laboratoy, Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: After 6 hours of Continuous Positive Airway Pressure treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05253963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.