Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy
|ClinicalTrials.gov Identifier: NCT01100554|
Recruitment Status : Unknown
Verified April 2010 by Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : April 9, 2010
Last Update Posted : April 13, 2010
|Condition or disease||Intervention/treatment||Phase|
|Bronchoscopy Obstructive Sleep Apnea Conscious Sedation||Device: Sleep endoscopy||Not Applicable|
Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a disorder characterized by recurrent upper airway collapse during sleep. Clinical consequences as increased cardiovascular events and automobile accidents were noted. Polysomnography is diagnostic while continuous positive airway pressure (CPAP) is the standard treatment. The adherence of CPAP treatment remained suboptimal, between 29 to 83%. In selected cases, alternative treatments were considered useful. However, how to choose candidates is still an issue.
Sleep endoscopy has been introduced since 1991 to allow direct visualization of the upper airway under sleep simulation. It predicts better outcome in non-adherent OSAHS patients who received alternative treatment. However, the ideal dose, drug, and sedative depth were not known.
Bispectral Index (BIS) monitor is a noninvasive neurophysiological monitoring device that been introduced since late 1990's. By applying a sensor to the forehead, the BIS obtained electroencephalograms(EEG) and electromyograms(EMG) which were transformed into simplified scaled numbers through 0-100. It has been applied in the real time monitor of anesthesia depth during operation or recovery, monitor of sleep in critical illness patients and gastrointestinal endoscopy sedation.
This study focuses on CPAP non-adherent patients. It evaluates the upper airway collapsibility in awake and two different sedative levels, BIS 65-75 (light sedation) and BIS 50-60(deep sedation). Conscious sedation will be achieved by propofol pump infusion. No benzodiazepam or opioid are used to avoid the effect of upper airway muscle tone and respiratory drive. The patency over the velopharynx, oropharynx, larynx, and hypopharynx will be recorded. Specific obstruction patterns such as tongue base retraction, epiglottis anterior-posterior decent, omega-shaped epiglottis,and bilateral arytenoids anterior drawing will also be recorded. The correlation of the upper airway collapsibility between sedative depth and sleep stages (ex. NREM vs. REM) will be evaluated. Besides, mandible advancement will be done under deep sedation. The response will guide further treatment choice for those CPAP non-adherent patient.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Upper Airway Collapsibility Evaluation in Different Sedative Levels by Sleep Endoscopy|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||June 2010|
|Experimental: all patients||
Device: Sleep endoscopy
Conscious sedation will be done under intravenous propofol infusion. The sedative level would be monitored and adjusted accord to the Bispectral Index monitor. After the adequate sedative level is achieved, a bronchoscopy (Olympus, BF) was inserted from the right nostril. The velopharynx, oropharynx, larynx, and hypopharynx obstructions were evaluated.
- Upper airway collapsibilityThe severity of upper aiwray collapses in different sedative levels will be evaluated by the sleep endoscopy. The correlation between the disease severities and airway collapsibilities will be evaluated.
- Mandible advancement response and oral appliance response [ Time Frame: 6 month and 1 year after oral appliance ]Patients with response to mandible advancement will be referred to oral appliance to treat OSA. The treatment outcome will be followed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100554
|Contact: Yung-Lun Ni, MD||886-3-3281200 ext email@example.com|
|Department or Thoracic Medicine, Chang Gung Memorial Hospital||Recruiting|
|Contact: Yung-Lun Ni, MD firstname.lastname@example.org|
|Study Director:||Yu-Lun Lo, MD||Chang Gung Memorial Hospital|