CompletedNot Applicable

Propofolsleep - A Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy (DISE)

Germany20 participantsStarted 2017-08-22

Plain-language summary

While Drug Induced Sleep Endoscopy (DISE) in patients with obstructive sleep apnea syndrome (OSAS) apnea and hypopnea occur. Because of the induced phases of apnea in a controlled setting it is possible to evaluate the related pathophysiology of apnea. We plan to correlate the Patient State Index (PSI) and other physiologic parameters with phases of apnea and hypopnea.

Who can participate

Age range

18 Years

Sex

ALL

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: * informed written consent * age of 18 years or older * no participation in other prospective interventional studies * OSAS with a polysomnographic shown AHI (apnea-hypopnea-index) of 15/h or more Exclusion Criteria: * no written informed consent * allergies against study medication * ASA (american society of anesthesiologists) class 4 or higher * neurodegenerative CNS (central nerve system) or muscle diseases * pregnant or breastfeeding patients * 25 % or more central or mixed apneas in polysomnography

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

PSI

Timeframe: Duration of surgery (an average of 2 hours)

Trial details

NCT IDNCT03224936

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-10-30

View on ClinicalTrials.gov More Sleep Apnea, Obstructive trials