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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01269073
Other study ID # IRB00005628
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 2011
Est. completion date December 2012

Study information

Verified date August 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This trial is enrolling patients who are already being seen at OHSU sleep disorder center or have been referred for clinical reasons by their physician to the OHSU sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons.

The purpose of this study is to determine whether the Portland sleep apnea quiz has a higher specificity and negative predictive value then the Berlin Sleep Questionnaire in a patient population with a high predisposition to sleep apnea presenting to a sleep center.


Description:

This trial is enrolling patients who are already being seen at OHSU sleep disorder center or have been referred for clinical reasons by their physician to the OHSU sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons.

400 consecutive adult subjects who have been referred by their doctor to the sleep disorder center and are undergoing a diagnostic sleep study at the OHSU sleep disorders center will be requested to fill out both a Berlin questionnaire and Portland sleep quiz on the night of the initial diagnostic polysomnography. The questionnaires will be collected and scored in a confidential manner. The predictive value of the questionnaires will be compared with the results of overnight polysomnography (Apnea Hypopnea Index).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Adults more than 18 years old

Exclusion Criteria:

- Subjects Unwilling to Complete the Questionnaire

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Akram Khan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of 2 questionnaires 24 months
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