NCT00674076

Brief Summary

We hypothesize the width air-colum of retropalatal region and tongue voulme by ultrsound through submental area is different between normal control with those with obstructive sleep apnea syndrome who was comfirmed by polysomography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 10, 2012

Status Verified

June 1, 2012

Enrollment Period

9 months

First QC Date

May 5, 2008

Last Update Submit

July 8, 2012

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • apnea-hypopnea index

    less than one month apart from ultrasound

Study Arms (2)

sleep apnea

a patient has been diagnosed as having obstructive sleep apnea

control

a case who has a negative polysomography or noraml score of Pittsburg sleep questionaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who are arranged to recived polysomography

You may qualify if:

  • group of sleep apnea: patients who have been diagnosed as having obstructive sleep apnea
  • control group: patients who have a negative polysomogrphy or a normal score of Pittsburg sleep questionaire

You may not qualify if:

  • Less than 18-year-old
  • un-willing
  • not co-operated person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.

    PMID: 23675433DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hao-Chien Wang, MD, PhD

    National Taiwan University Hospital, Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 10, 2012

Record last verified: 2012-06

Locations

TW(1)