Drug Induced Submental Ultrasound in Obstructive Sleep Apnea Patients

Obstructive Sleep Apnea Clinical Trial

Official title:

Correlative Analysis of Upper Airway Collapse in Sleep Endoscope and Submental Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03285451
• Other study ID #: 06-X07-017
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2017
• Last updated: September 14, 2017
• Start date: May 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2017
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: Ming-Chin Lan, MD
• Phone: +886920734552
• Email: lanmingchin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• submental ultrasonography
Submental ultrasound, the noninvasive and convenient tool, has been widely applied to measure the tongue base thickness in patients with obstructive sleep apnea, so as to predict the severity and relationship with upper airway collapse.

Locations

Country	Name	City	State
Taiwan	Taipei Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The value of drug induced sleep ultrasonography in patients with obstructive sleep apnea	In this study, we proposed a novel method, drug induced sleep ultrasonography (DISU), which was applied to measure the tongue base thickness in OSA patients during drug induced sleep, so as to further understand the impact of dynamic change of tongue base thickness in OSA patients.	May, 2017 to Aug, 2017