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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03285451
Other study ID # 06-X07-017
Secondary ID
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
Health authority
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)

Study Design


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
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