Sleep Disordered BreathingNCT00922168
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients
An observational study of Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Cleveland Medical Devices Inc at 2 sites in United States.
Trial summary
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Central Sleep Apnea
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Aug 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cardiac surgery patients
Who may be able to join
- Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.
- Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.
Who cannot join
- Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.
- Subjects undergoing Maze procedure for atrial fibrillation.
- Subjects unable to comply with study procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Official title: Pre-operative PSG Assessment of Cardiac Surgery Inpatients
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.
- Keywords
- Sleep, apnea, obstructive, central
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Apnea, Central, Apnea
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 |
|---|---|---|
| Cardiac Surgeries: CABG, valve replacements | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients
Measured: September 2009
Secondary outcomes (1)
Assess Post-Operative Complications of Patients with Sleep Disordered Breathing
Measured: September 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startMar 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies 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
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Medical Devices Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), The Cleveland Clinic, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Hani A Kayyali, MS, Principal investigator, Cleveland Medical Devices IncNancy Foldvary, DO, Principal investigator, The Cleveland ClinicNancy Collop, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922168
- Sponsor's protocol ID
- Pre-op PSG
- Other IDs
- R44NS042451
- Status last verified
- Feb 2014
- First submitted
- 15 Jun 2009
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative PSG Assessment of Cardiac Surgery Inpatients
- ClinicalTrials.gov ID
- NCT00922168
- Acronym / sponsor ID
- Pre-op PSG
- Keywords
- Sleep, apnea, obstructive, central
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Cleveland Medical Devices IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), The Cleveland Clinic, Johns Hopkins University
- Study start
- Mar 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 17 Jun 2009 (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.
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgeries: CABG, valve replacements | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cardiac surgery patients
Key inclusion criteria (2 listed)
- Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.
- Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.
Key exclusion criteria (3 listed)
- Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.
- Subjects undergoing Maze procedure for atrial fibrillation.
- Subjects unable to comply with study procedures.
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
Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients
Time frame: September 2009
1 secondary outcome
Assess Post-Operative Complications of Patients with Sleep Disordered Breathing
Time frame: September 2009
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 6 Feb 2014.
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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.
Hani A Kayyali, MS principal investigator
Cleveland Medical Devices Inc
Nancy Foldvary, DO principal investigator
The Cleveland Clinic
Nancy Collop, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Cleveland Medical Devices Inc at 2 sites 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 3 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients (time frame: September 2009). 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 6 Feb 2014.