Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2030-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study has investigated the reliability of this technique, demonstrating moderate-substantial interrater and test-retest reliability. This research has also compared DISE findings to those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not responded to previous sleep apnea surgery. These papers have been published and available through PubMed. Additional research is ongoing, with examination of DISE findings, comparison to other evaluation techniques, and the association between DISE findings and surgical outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Natural Sleep and Drug-induced Sleep Endoscopy

NCT03004014

Obstructive Sleep Apnea

COMPLETED NA

Evaluation in Patients With Obstructive Sleep Apnea That Had Undergone Diagnosis and Surgical Treatment

NCT02977338

OSA

UNKNOWN

Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea

NCT02855515

Obstructive Sleep Apnoea Sleep-Disordered Breathing

COMPLETED NA

Effects of Lung Volume on Upper Airway Patency During Drug Induced Sleep Endoscopy

NCT05350332

Obstructive Sleep Apnea

RECRUITING NA

Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea

NCT04729478

Sleep Apnea, Obstructive Sleep Apnea Sleep Apnea Syndromes +13 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea, Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

OSA Patients considering surgical treatment

Group Type OTHER

Propofol sedation

Intervention Type DRUG

Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol sedation

Patients receive an intravenous propofol infusion titrated to reach a target level of sedation, sleep with arousability to verbal stimuli.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients with OSA considering surgical treatment

Exclusion Criteria

* Minors
* Pregnant women
* Patients unable to provide informed consent in English themselves
* Prisoners
* Allergy to propofol, soybean oil, egg lecithin or glycerol
* Other contraindication to use of propofol (decision of anesthesiologist or otolaryngologist.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No