Sleep ApneaNCT01269073
Comparison Of The Berlin Questionnaire To The Portland Sleep Quiz
An observational study of Sleep Apnea, run by Akram Khan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sleep Apnea
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults presenting to a sleep center
Who may be able to join
- Adults more than 18 years old
Who cannot join
- Subjects Unwilling to Complete the Questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Comparison Of The Berlin Questionnaire To The Portland Sleep Quiz In Identification Of Patients At Risk For Obstructive Sleep Apnea
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.
Read the detailed 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).
- Conditions
- Sleep Apnea
- Keywords
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 2 questionnaires
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akram Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Akram Khan, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269073
- Sponsor's protocol ID
- IRB00005628
- Status last verified
- Aug 2019
- First submitted
- 3 Jan 2011
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Berlin Questionnaire To The Portland Sleep Quiz In Identification Of Patients At Risk For Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01269073
- Acronym / sponsor ID
- IRB00005628
- Conditions
- Sleep Apnea
- Keywords
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Akram KhanUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults presenting to a sleep center
Key inclusion criteria (1 listed)
- Adults more than 18 years old
Key exclusion criteria (1 listed)
- Subjects Unwilling to Complete the Questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of 2 questionnaires
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Akram Khan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of 2 questionnaires (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.