CompletedNot Applicable

Upper Airway of Women With Obstructive Sleep Apnea After Bariatric Surgery

Brazil38 participantsStarted 2017-08-15

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Upper airway changes after surgical weight loss

Timeframe: 6 months

Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss

Timeframe: 6 months

Changes in volumes and areas of upper airway

Timeframe: 6 months

Correlation between the changes on upper airway with the changes on obstructive sleep apnea

Timeframe: 6 months

Trial details

NCT IDNCT05669469

SponsorMichel Burihan Cahali

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-03-25

View on ClinicalTrials.gov More Sleep Apnea trials

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Upper airway changes after surgical weight loss

Timeframe: 6 months

Obstructive sleep apnea parameters measured thought polysomnographic changes after weight loss

Timeframe: 6 months

Changes in volumes and areas of upper airway

Timeframe: 6 months

Correlation between the changes on upper airway with the changes on obstructive sleep apnea

Timeframe: 6 months