Drug Induced Submental Ultrasound in Obstructive Sleep Apnea Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: submental ultrasonography

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ming-Chin Lan, MD; Phone Number: +886920734552; Email: lanmingchin@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 231
    • Recruiting
    • Taipei Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation
    • Contact: Ming-Chin Lan, MD; Phone Number: +886920734552; Email: lanmingchin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Investigators: Study Chair: Ming-Chin Lan, MD, Taipei Tzu Chi Hospita l Buddhist Tzu Chi Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Submental ultrasound, Obstructive sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 06-X07-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No