Obstructive Sleep ApneaPROSPECTNCT00785070
Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)
An observational study of Obstructive Sleep Apnea, run by Memorial Health System at 1 site in United States.
Trial summary
Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System) Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep study device results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopedic Total Hip or Knee Joint Replacement
Who may be able to join
- Undergoing knee or hip total joint replacement
- Answer Yes to any PROSPECT health history questions and/or score Positive on the sleep questionnaires
Who cannot join
- Tape Allergy
- Previous Diagnosis Of Obstructive Sleep Apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Health System
Colorado Springs, Colorado, 80909
About this study
- Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System)
- Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep study device results.
- Evaluate effectiveness of the home sleep study testing in the orthopedic presurgical population.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Perioperative, Obstructive Sleep Apnea, Screening, Home Sleep Testing
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Perioperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of objective sleep data to standardized sleep questionnaires
Measured: Pre and Post Operative
Secondary outcomes (1)
Compare Pre and Post Operative Objective sleep data
Measured: Pre and post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Nexan Inc
- Investigators
- Clayton B. Carr, M.D., Principal investigator, Memorial Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785070
- Sponsor's protocol ID
- PROSPECT
- Acronym
- PROSPECT
- Status last verified
- Feb 2009
- First submitted
- 4 Nov 2008
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)
- ClinicalTrials.gov ID
- NCT00785070
- Acronym / sponsor ID
- PROSPECT / PROSPECT
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Perioperative, Obstructive Sleep Apnea, Screening, Home Sleep Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Memorial Health SystemUniversity, hospital or other
- Collaborators
- Nexan Inc
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 5 Nov 2008 (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.
- Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System)
- Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep study device results.
- Evaluate effectiveness of the home sleep study testing in the orthopedic presurgical population.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Perioperative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopedic Total Hip or Knee Joint Replacement
Key inclusion criteria (2 listed)
- Undergoing knee or hip total joint replacement
- Answer Yes to any PROSPECT health history questions and/or score Positive on the sleep questionnaires
Key exclusion criteria (2 listed)
- Tape Allergy
- Previous Diagnosis Of Obstructive Sleep Apnea
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 objective sleep data to standardized sleep questionnaires
Time frame: Pre and Post Operative
1 secondary outcome
Compare Pre and Post Operative Objective sleep data
Time frame: Pre and post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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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.
Clayton B. Carr, M.D. principal investigator
Memorial Health System
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 Obstructive Sleep Apnea, run by Memorial Health System 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 9 Feb 2009. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 objective sleep data to standardized sleep questionnaires (time frame: Pre and Post Operative). 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 9 Feb 2009.