Sleep Duration on the First Night After SurgeryNCT01551485
Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
A study testing Zolpidem in people with Sleep Duration on the First Night After Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Sleep after surgery has been found to be very distrubed immediately after major surgery. This is also seen after fast-track hip and knee replacement with length of stay of less than 3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and decline in cognitive abilities. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep Duration on the First Night After Surgery
- What is being tested?
- Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Oct 2012
- Phase
- Interventional
- 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
Who may be able to join
- Total hip or knee replacement in fast-track setup
- Age 60 years or above
- ASA class 1-3
Who cannot join
- Anesthesia within the pas 30 days
- Daily use of alcohol > 21 units / week
- Use of anxiolytics or hypnotics within the past 30 days
- Inability to read and understand Danish
- Marked reduction of sight or hearing
- Parkinson's disease or other neurological disaese causing function deficits
- Inability to cooperate to sleep monitoring
- allergy to the drug tested
Trial locations and contacts
1 site in 1 country.
About this study
Sleep after surgery has been found to be very distrubed immediately after major surgery. This is also seen after fast-track hip and knee replacement with length of stay of less than 3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and decline in cognitive abilities.
- Being tested
- Zolpidem, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG
PlaceboDrug
Pacebo tablet, blinded given on the first night after surgery
| Study group | Role | What they receive |
|---|---|---|
| Zolpidem | Experimental | Not described Receives: Drug: Zolpidem |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep time on the first postoperative night compared to preoperatively.
The primary endpoint is an evaluation of sleep stages on the first night postoperatively compared to preoperative measures for the same individual
Measured: first night postoperatively - 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Duration on the First Night After SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Krenk, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lene Krenk, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551485
- Sponsor's protocol ID
- H-3-2011-022
- Status last verified
- Aug 2012
- First submitted
- 6 Feb 2012
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.
PubMed 24634631
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
- ClinicalTrials.gov ID
- NCT01551485
- Acronym / sponsor ID
- H-3-2011-022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 12 Mar 2012 (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.
Sleep after surgery has been found to be very distrubed immediately after major surgery. This is also seen after fast-track hip and knee replacement with length of stay of less than 3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and decline in cognitive abilities.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zolpidem | Experimental | Drug: Zolpidem |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total hip or knee replacement in fast-track setup
- Age 60 years or above
- ASA class 1-3
Key exclusion criteria (8 listed)
- Anesthesia within the pas 30 days
- Daily use of alcohol > 21 units / week
- Use of anxiolytics or hypnotics within the past 30 days
- Inability to read and understand Danish
- Marked reduction of sight or hearing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZolpidemThe effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG | Drug | Zolpidem |
| PlaceboPacebo tablet, blinded given on the first night after surgery | Drug | Placebo |
Primary outcome
Change in sleep time on the first postoperative night compared to preoperatively.
Time frame: first night postoperatively - 24 hours
The primary endpoint is an evaluation of sleep stages on the first night postoperatively compared to preoperative measures for the same individual
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
- Derived from this study: PubMed 24634631Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.
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, MD 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?
A study testing Zolpidem in people with Sleep Duration on the First Night After Surgery, 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Aug 2012. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change in sleep time on the first postoperative night compared to preoperatively. (time frame: first night postoperatively - 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551485, which also lists 1 linked publication.
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 8 Aug 2012.