Clinical trial NCT03285451: Drug Induced Submental Ultrasound in Obstructive Sleep Apnea Patients
Official title: Correlative Analysis of Upper Airway Collapse in Sleep Endoscope and Submental Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Keywords: Submental ultrasound, Obstructive sleep apnea
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstructive sleep apnea patients, age between 20-70 without severe heart, lung, liver, and kidney comorbidity or propofol or dexmedetomidine allergies

Brief summary: In this study, submental ultrasound during awake and simultaneous under Drug-induced sleep endoscopy is applied in the diagnostic workup of obstructive sleep apnea patients. The aim is to assess the tongue base thickness during awake and sleep with different head positions. By correlation with Drug-induced sleep endoscopy findings, more parameters could be used for evaluation and management of upper airway collapse in obstructive sleep apnea patients.

Detailed description: Obstructive sleep apnea (OSA) is a syndrome characterized by recurrent episodes of apnea and hypopnea during sleep that are caused by repetitive upper airway (UA) collapse and often result in decreased blood oxygen levels and arousal from sleep. Successful treatment lies in precise mapping the site of airway narrowing.

Drug-induced sleep endoscopy (DISE) is a well described modality to mimic the dynamic change of UA in OSA patients during natural sleep. Nevertheless, the tongue base thickness (TBT), one of the important anatomic factors in OSA, is hard to evaluate under this method. Recently, submental ultrasound (US), the noninvasive and convenient tool, has been widely applied to measure the TBT in awake OSA patients, so as to predict the severity and relationship with UA collapse. However, few evidence has addressed the relationship between UA collapse and the TBT in different head positions, awake and sleep period In this study, submental US during awake and drug induced sleep period is applied in the diagnostic workup of OSA patients. By correlation with DISE findings, more parameters could be used for evaluation and management of upper airway collapse in OSA patients.

Key Words: Submental ultrasound, Obstructive sleep apnea, Drug-induced sleep endoscopy

Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnea patients, age between 20-70

Exclusion Criteria:

* severe heart, lung, liver, and kidney comorbidity propofol or dexmedetomidine allergies (albeit rare)

Primary outcomes:
measure: The value of drug induced sleep ultrasonography in patients with obstructive sleep apnea
timeFrame: May, 2017 to Aug, 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation
Study officials:
affiliation: Taipei Tzu Chi Hospita l Buddhist Tzu Chi Medical Foundation
name: Ming-Chin Lan, MD
role: STUDY_CHAIR
References: