NCT03285451

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 18, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

September 14, 2017

Last Update Submit

September 14, 2017

Conditions

Keywords

Submental ultrasound, Obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Obstructive sleep apnea patients, age between 20-70

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Taipei, 231, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ming-Chin Lan, MD

    Taipei Tzu Chi Hospita l Buddhist Tzu Chi Medical Foundation

    STUDY CHAIR

Central Study Contacts

Ming-Chin Lan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

May 1, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

September 18, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations