REM Sleep MeasurementNCT01144130
Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement
An observational study of REM Sleep Measurement, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to quantify the degree of sleep disturbances after hip or knee replacement surgery. Through polysomnographic monitoring the disturbances in sleep stages will be clarified. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- REM Sleep Measurement
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- May 2010to Oct 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients above 60 years undergoing hip/knee replacement surgery in a fest track set-up.
Who may be able to join
- above 60
- ASA classification I-IV
Who cannot join
- general anaesthesia within 90 days
- daily use of sedatives
- alcohol abuse
- insufficient written and verbal Danish
- severe hearing loss and poor sight
- Parkinsons Disease or other functional neurological deficits
- Mini mental status < 24
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to quantify the degree of sleep disturbances after hip or knee replacement surgery.
Through polysomnographic monitoring the disturbances in sleep stages will be clarified.
- Conditions
- REM Sleep Measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of REM sleep before and first postoperative night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep MeasurementStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Center for Fast-Track Hip and Knee Replacement
- Investigators
- Lene Krenk, Doctor, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144130
- Sponsor's protocol ID
- H-2-2010-011
- Status last verified
- Oct 2010
- First submitted
- 14 Jun 2010
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement
- ClinicalTrials.gov ID
- NCT01144130
- Acronym / sponsor ID
- H-2-2010-011
- Conditions
- REM Sleep Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Lundbeck Center for Fast-Track Hip and Knee Replacement
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Jun 2010 (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 quantify the degree of sleep disturbances after hip or knee replacement surgery.
Through polysomnographic monitoring the disturbances in sleep stages will be clarified.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients above 60 years undergoing hip/knee replacement surgery in a fest track set-up.
Key inclusion criteria (2 listed)
- above 60
- ASA classification I-IV
Key exclusion criteria (7 listed)
- general anaesthesia within 90 days
- daily use of sedatives
- alcohol abuse
- insufficient written and verbal Danish
- severe hearing loss and poor sight
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
Duration of REM sleep before and first postoperative night
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 20 Sep 2011.
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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.
Lene Krenk, Doctor principal investigator
Copenhagen University Hospital, Rigshospitalet
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 REM Sleep Measurement, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 7 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 20 Sep 2011. 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 Denmark. 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?
Duration of REM sleep before and first postoperative night. 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 20 Sep 2011.