Sleep ApneaNCT05669469
Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery
An observational study of Sleep Apnea and Obesity, run by Michel Burihan Cahali at 1 site in Brazil.
Trial summary
Evaluation of upper airway with Magnetic Resonance and polysomnographic at the pre and post operative of 23 women having undergone bariatric surgery (with the Y-Roux technique) for treatment of obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Sleep Apnea, Obesity
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2017to 2 Apr 2022
- Phase
- Observational
- 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 to 70 years
- Women only
- Adult, Older adult
Study population: The patients were recruited in a center for the treatment of obesity after being referenced by the general practitioner to bariatric surgery. All patients apt for the bariatric surgery have attended weekly multi-professional accompaniment (medical, nursing, nutritional, physiotherapy and psychology) for a 16-week period, being subjected to weight loss through diet counselling, practice of physical activities and changes in life habits. The clinical and polysomnographic evaluations for this study have been carried out between 1 and 7 days before the bariatric surgeries. The magnetic resonance of the upper airways was performed on the eve of the bariatric surgery. At least 6 months after the surgeries, patients underwent a repeated polysomnography and Magnetic Resonance.
Who may be able to join
- patients with a recommendation and considered apt for bariatric surgery by the multi-professional group
- aged between 18 and 70
- with a residual (after the 16-week period) BMI above 35 kg/m2
- polysomnographic obstructive sleep apnea diagnosis: Apnea-Hypopnea Index (AHI) above 5 events per hour associated with a co-morbidity and/or complaints of snoring.
Who cannot join
- patients with body weight above 180 kg - for the impossibility of having a magnetic resonance (MR)
- carrying metal artifacts which contraindicate the performing of MR
- patients with a history of pharyngeal or neoplasia in the head and neck region
- patients affected by gross craniofacial deformities
- pregnant women
- previous UA surgery for OSA
- patients undergoing any other treatment for OSA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upper Airway of Women With Obstructive Sleep Apnea Changes After Bariatric Surgery and a Possible Influence of Menopause
Evaluation of upper airway with Magnetic Resonance and polysomnographic at the pre and post operative of 23 women having undergone bariatric surgery (with the Y-Roux technique) for treatment of obesity.
Read the detailed description
The the present study aims at describing the modifications occurring in the upper airway (UA) and the impact of such modifications on the severity of obstructive sleep apnea after bariatric surgery in women who have obstructive sleep apnea (OSA). The hypothesis is that the massive weight loss after bariatric surgery on OSA women could modify the UA more intensely than previously reported by other therapies for weight loss and that the menopause status may influence the likely reshaping of UA after bariatric surgery.
- Conditions
- Sleep Apnea, Obesity
- Being tested
- Bariatric surgery
- Keywords
- Sleep Apnea, Obesity, Bariatric Surgery
- Medical subject headings
- Sleep Apnea Syndromes, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Also called surgical weight loss, Y-Roux
- gastric pouch creation, 2) creation of biliopancreatic limb, 3) jejunojejunostomy creation, and 4) creation of gastrojejunostomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper airway changes after surgical weight loss
Changes in weight (kilograms) measured before and six months after the bariatric surgery.
Measured: 6 months
Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss
Comparison of pre and post polysomnographic indexes: (apnea hypopnea index (AHI), arousals index, AHI at rapid eye movement (REM) sleep, AHI at supine position)
Measured: 6 months
Changes in volumes and areas of upper airway
Changes through MRI of measures upper airway and volume of tissues, as the percent of fat tissue within (in millimeters and %)
Measured: 6 months
Correlation between the changes on upper airway with the changes on obstructive sleep apnea
Pearson correlation between the changes occurred on upper airway measures and polysomnographic after the procedure
Measured: 6 months
Secondary outcomes (1)
Evaluation if the menstrual status interfere on outcomes
Participants are divided between menses and menopause groups; evaluation of the changes occurred on weight (kilograms), upper airway measures (millimeters and percentages) and polysomnographic (apnea hypopnea indexes) are different according menstrual status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start15 Aug 2017
- Primary completion25 Mar 2021
- Study completion2 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michel Burihan Cahali
- Sponsor type
- University, hospital or other
- Collaborators
- Carolina Ferraz de Paula Soares
- Responsible party
- Sponsor-investigator, Michel Burihan Cahali, University of Sao Paulo General Hospital
- Investigators
- Michel Cahali, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669469
- Sponsor's protocol ID
- 66609117.9.0000.0065
- Status last verified
- Dec 2022
- First submitted
- 12 Nov 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: as described in the informed consent form, the data collected in the research would not be shared with the patients, but they could, at the end of the study, request copies of the tests performed.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Airway of Women With Obstructive Sleep Apnea Changes After Bariatric Surgery and a Possible Influence of Menopause
- ClinicalTrials.gov ID
- NCT05669469
- Acronym / sponsor ID
- 66609117.9.0000.0065
- Conditions
- Sleep Apnea, Obesity
- Keywords
- Sleep Apnea, Obesity, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Michel Burihan CahaliUniversity, hospital or other
- Collaborators
- Carolina Ferraz de Paula Soares
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 2 Apr 2022 (actual)
- First posted
- 30 Dec 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.
Evaluation of upper airway with Magnetic Resonance and polysomnographic at the pre and post operative of 23 women having undergone bariatric surgery (with the Y-Roux technique) for treatment of obesity.
Detailed description
The the present study aims at describing the modifications occurring in the upper airway (UA) and the impact of such modifications on the severity of obstructive sleep apnea after bariatric surgery in women who have obstructive sleep apnea (OSA). The hypothesis is that the massive weight loss after bariatric surgery on OSA women could modify the UA more intensely than previously reported by other therapies for weight loss and that the menopause status may influence the likely reshaping of UA after bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The patients were recruited in a center for the treatment of obesity after being referenced by the general practitioner to bariatric surgery. All patients apt for the bariatric surgery have attended weekly multi-professional accompaniment (medical, nursing, nutritional, physiotherapy and psychology) for a 16-week period, being subjected to weight loss through diet counselling, practice of physical activities and changes in life habits. The clinical and polysomnographic evaluations for this study have been carried out between 1 and 7 days before the bariatric surgeries. The magnetic resonance of the upper airways was performed on the eve of the bariatric surgery. At least 6 months after the surgeries, patients underwent a repeated polysomnography and Magnetic Resonance.
Key inclusion criteria (4 listed)
- patients with a recommendation and considered apt for bariatric surgery by the multi-professional group
- aged between 18 and 70
- with a residual (after the 16-week period) BMI above 35 kg/m2
- polysomnographic obstructive sleep apnea diagnosis: Apnea-Hypopnea Index (AHI) above 5 events per hour associated with a co-morbidity and/or complaints of snoring.
Key exclusion criteria (7 listed)
- patients with body weight above 180 kg - for the impossibility of having a magnetic resonance (MR)
- carrying metal artifacts which contraindicate the performing of MR
- patients with a history of pharyngeal or neoplasia in the head and neck region
- patients affected by gross craniofacial deformities
- pregnant women
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 |
|---|---|---|
| Bariatric surgeryAlso: surgical weight loss, Y-Roux1) gastric pouch creation, 2) creation of biliopancreatic limb, 3) jejunojejunostomy creation, and 4) creation of gastrojejunostomy. | Procedure or surgery | – |
Primary outcome
Upper airway changes after surgical weight loss
Time frame: 6 months
Changes in weight (kilograms) measured before and six months after the bariatric surgery.
Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss
Time frame: 6 months
Comparison of pre and post polysomnographic indexes: (apnea hypopnea index (AHI), arousals index, AHI at rapid eye movement (REM) sleep, AHI at supine position)
Changes in volumes and areas of upper airway
Time frame: 6 months
Changes through MRI of measures upper airway and volume of tissues, as the percent of fat tissue within (in millimeters and %)
Correlation between the changes on upper airway with the changes on obstructive sleep apnea
Time frame: 6 months
Pearson correlation between the changes occurred on upper airway measures and polysomnographic after the procedure
1 secondary outcome
Evaluation if the menstrual status interfere on outcomes
Time frame: 6 months
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 30 Dec 2022.
- Individual participant dataSharing planned: No. as described in the informed consent form, the data collected in the research would not be shared with the patients, but they could, at the end of the study, request copies of the tests performed.
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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.
Michel Cahali, PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Obesity, run by Michel Burihan Cahali 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 4 inclusion and 7 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 30 Dec 2022. 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?
Upper airway changes after surgical weight loss (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2022.