Sleep DisturbanceNCT04227873
Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty
An observational study of Sleep Disturbance and Delirium, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Sleep and rest are key elements in postoperative rehabilitation and recovery. There are complex relations between major surgery, sleep disturbance and complications. Major surgery leeds to severe postoperative sleep disturbances, initially reducing REM sleep time and disturbing the remaining sleep stages. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Disturbance, Delirium, Arthroplasty Complications
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2020to Jul 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 16 adult attending scheduled hip or knee arthroplasty in an ambulatory fast-track setting with spinal anesthesia corresponding to the above mentioned inclusion criteria.
Who may be able to join
- ASA classification I or II
- Scheduled hospital discharge same day after surgery
- Adult person following the patient 24 hours at the patients habitation
- Informed consent and signature.
- Patient speaks and understands Danish
Who cannot join
- Hospital discharge later than same day after surgery
- No consent form patient
- Alcohol or drug abuse
- Anxiolytic og antipsychotic treatment
- Preoperative opioid treatment
- Soporific treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hvidovre Hospital
Hvidovre, 2650
Alexandre Garioud, MD, +4542705009, alexandre.garioud@gmail.com
Nicolai B Foss, Dr.med,Phd, +45 36 32 53 28, nicolai.bang.foss@regionh.dk
About this study
Sleep and rest are key elements in postoperative rehabilitation and recovery. There are complex relations between major surgery, sleep disturbance and complications. Major surgery leeds to severe postoperative sleep disturbances, initially reducing REM sleep time and disturbing the remaining sleep stages. Major surgery is again a risk factor for postoperative delirium and other cognitive impairment. The underlying mechanisms includes pain, opioid medication, sleep disturbances and neuroinflammation, along with external factors as noise during hospitalisation. The physiologic stress from sleep disturbances and sleep deprivation is associated with blood-brain barrier impairment, inflammation, decreased restitution, altered nociceptive function. Likewise, undiagnosed and untreated sleep apnea is a risk for postoperative complications and is itself affected by anesthesia and some analgesics (i.a. opioids).
Fast-track surgery development has led to restitution period shortening, optimized pain management reducing opioid use, postoperative inflammatory stress response reduction and less delirium. Evolution of hip and knee arthroplasty(THA/TKA), organisation, optimized pain management and pharmacologic modification of inflammatory response by high dose steroid has permitted to perform these surgeries in an outpatient setting.
Read more
Previous studies of fast-track THA/TKA using multimodal opioid-sparring analgesia, however neither using high dose steroids nor in an out patient setting, have demonstrated REM sleep period reduction from a normal range of 18% preoperatively to 1% postoperatively. However, changes in sleep architecture after THA/TKA in at setting attempting to minimise abnormal sleep by means of ambulatory surgery added to perioperative reduction of inflammatory response to surgery, pain and opioid use by high dose steroid, haven't been studied.
The purpose of this study is to investigate how much an optimized ambulatory THA/TKA , reducing pain and inflammatory response to surgery and opioid use by high doses steroid can conserve the preoperative sleep architecture.
- Conditions
- Sleep Disturbance, Delirium, Arthroplasty Complications
- Medical subject headings
- Parasomnias, Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postoperative REM sleep time compared to preoperative
Polysomnography
Measured: One night 2 to 4 night preoperatively, and the first and second postoperative night.
Secondary outcomes (3)
Changes Remaining sleep stages and sleep variables (i.a. apnea)
Polysomnography
Measured: One night 2 to 4 night preoperatively, and the first and second postoperative night.
Presence and severity of postoperative delirium compared to preoperative
Confusion Assessement Method-Severity (CAM-S). High scores, better outcome.
Measured: One night 2 to 4 night preoperatively, and after the second postoperative night.
Presence and severity of postoperative cognitive impairment compared to preoperative
Mini Mental State Examination (MMSE), High scores, better outcome.
Measured: One night 2 to 4 night preoperatively, and after the second postoperative night.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D., Nicolai Bang Foss, Poul Jenum, Anders Troelsen, Kirill Gromov, Mette Grentoft, Henning Piilgaard Hansen
- Responsible party
- Principal investigator, Alexandre Garioud, Hvidovre University Hospital
- Investigators
- Henrik Kehlet, Dr.med,Phd, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227873
- Sponsor's protocol ID
- HVH01
- Status last verified
- Feb 2020
- First submitted
- 12 Dec 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
PubMed 28187050Inouye SK, Kosar CM, Tommet D, Schmitt EM, Puelle MR, Saczynski JS, Marcantonio ER, Jones RN. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014 Apr 15;160(8):526-533. doi: 10.7326/M13-1927.
PubMed 24733193Keats AS. The ASA classification of physical status--a recapitulation. Anesthesiology. 1978 Oct;49(4):233-6. doi: 10.1097/00000542-197810000-00001. No abstract available.
PubMed 697075Krenk L, Rasmussen LS, Kehlet H. New insights into the pathophysiology of postoperative cognitive dysfunction. Acta Anaesthesiol Scand. 2010 Sep;54(8):951-6. doi: 10.1111/j.1399-6576.2010.02268.x. Epub 2010 Jul 12.
PubMed 20626359Krenk 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 24634631Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Nov;109(5):769-75. doi: 10.1093/bja/aes252. Epub 2012 Jul 24.
PubMed 22831887Riedel B, Browne K, Silbert B. Cerebral protection: inflammation, endothelial dysfunction, and postoperative cognitive dysfunction. Curr Opin Anaesthesiol. 2014 Feb;27(1):89-97. doi: 10.1097/ACO.0000000000000032.
PubMed 24300462Ni P, Dong H, Zhou Q, Wang Y, Sun M, Qian Y, Sun J. Preoperative Sleep Disturbance Exaggerates Surgery-Induced Neuroinflammation and Neuronal Damage in Aged Mice. Mediators Inflamm. 2019 Mar 18;2019:8301725. doi: 10.1155/2019/8301725. eCollection 2019.
PubMed 31011286He J, Hsuchou H, He Y, Kastin AJ, Wang Y, Pan W. Sleep restriction impairs blood-brain barrier function. J Neurosci. 2014 Oct 29;34(44):14697-706. doi: 10.1523/JNEUROSCI.2111-14.2014.
PubMed 25355222McMahon WR, Ftouni S, Drummond SPA, Maruff P, Lockley SW, Rajaratnam SMW, Anderson C. The wake maintenance zone shows task dependent changes in cognitive function following one night without sleep. Sleep. 2018 Oct 1;41(10). doi: 10.1093/sleep/zsy148.
PubMed 30169703de Raaff CAL, Gorter-Stam MAW, de Vries N, Sinha AC, Jaap Bonjer H, Chung F, Coblijn UK, Dahan A, van den Helder RS, Hilgevoord AAJ, Hillman DR, Margarson MP, Mattar SG, Mulier JP, Ravesloot MJL, Reiber BMM, van Rijswijk AS, Singh PM, Steenhuis R, Tenhagen M, Vanderveken OM, Verbraecken J, White DP, van der Wielen N, van Wagensveld BA. Perioperative management of obstructive sleep apnea in bariatric surgery: a consensus guideline. Surg Obes Relat Dis. 2017 Jul;13(7):1095-1109. doi: 10.1016/j.soard.2017.03.022. Epub 2017 Mar 30.
PubMed 28666588Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. No abstract available.
PubMed 23663938Kehlet H, Lindberg-Larsen V. High-dose glucocorticoid before hip and knee arthroplasty: To use or not to use-that's the question. Acta Orthop. 2018 Oct;89(5):477-479. doi: 10.1080/17453674.2018.1475177. Epub 2018 May 21. No abstract available.
PubMed 29781366Krenk L, Rasmussen LS, Hansen TB, Bogo S, Soballe K, Kehlet H. Delirium after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Apr;108(4):607-11. doi: 10.1093/bja/aer493. Epub 2012 Jan 24.
PubMed 22277666Gromov K, Kjaersgaard-Andersen P, Revald P, Kehlet H, Husted H. Feasibility of outpatient total hip and knee arthroplasty in unselected patients. Acta Orthop. 2017 Oct;88(5):516-521. doi: 10.1080/17453674.2017.1314158. Epub 2017 Apr 20.
PubMed 28426262
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04227873
- Acronym / sponsor ID
- HVH01
- Conditions
- Sleep Disturbance, Delirium, Arthroplasty Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D., Nicolai Bang Foss, Poul Jenum, Anders Troelsen, Kirill Gromov, Mette Grentoft, Henning Piilgaard Hansen
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 14 Jan 2020 (actual)
- 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 and rest are key elements in postoperative rehabilitation and recovery. There are complex relations between major surgery, sleep disturbance and complications. Major surgery leeds to severe postoperative sleep disturbances, initially reducing REM sleep time and disturbing the remaining sleep stages. Major surgery is again a risk factor for postoperative delirium and other cognitive impairment. The underlying mechanisms includes pain, opioid medication, sleep disturbances and neuroinflammation, along with external factors as noise during hospitalisation. The physiologic stress from sleep disturbances and sleep deprivation is associated with blood-brain barrier impairment, inflammation, decreased restitution, altered nociceptive function. Likewise, undiagnosed and untreated sleep apnea is a risk for postoperative complications and is itself affected by anesthesia and some analgesics (i.a. opioids).
Fast-track surgery development has led to restitution period shortening, optimized pain management reducing opioid use, postoperative inflammatory stress response reduction and less delirium. Evolution of hip and knee arthroplasty(THA/TKA), organisation, optimized pain management and pharmacologic modification of inflammatory response by high dose steroid has permitted to perform these surgeries in an outpatient setting.
Previous studies of fast-track THA/TKA using multimodal opioid-sparring analgesia, however neither using high dose steroids nor in an out patient setting, have demonstrated REM sleep period reduction from a normal range of 18% preoperatively to 1% postoperatively. However, changes in sleep architecture after THA/TKA in at setting attempting to minimise abnormal sleep by means of ambulatory surgery added to perioperative reduction of inflammatory response to surgery, pain and opioid use by high dose steroid, haven't been studied.
The purpose of this study is to investigate how much an optimized ambulatory THA/TKA , reducing pain and inflammatory response to surgery and opioid use by high doses steroid can conserve the preoperative sleep architecture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 16 adult attending scheduled hip or knee arthroplasty in an ambulatory fast-track setting with spinal anesthesia corresponding to the above mentioned inclusion criteria.
Key inclusion criteria (5 listed)
- ASA classification I or II
- Scheduled hospital discharge same day after surgery
- Adult person following the patient 24 hours at the patients habitation
- Informed consent and signature.
- Patient speaks and understands Danish
Key exclusion criteria (6 listed)
- Hospital discharge later than same day after surgery
- No consent form patient
- Alcohol or drug abuse
- Anxiolytic og antipsychotic treatment
- Preoperative opioid treatment
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
Changes in postoperative REM sleep time compared to preoperative
Time frame: One night 2 to 4 night preoperatively, and the first and second postoperative night.
Polysomnography
3 secondary outcomes
Changes Remaining sleep stages and sleep variables (i.a. apnea)
Time frame: One night 2 to 4 night preoperatively, and the first and second postoperative night.
Presence and severity of postoperative delirium compared to preoperative
Time frame: One night 2 to 4 night preoperatively, and after the second postoperative night.
Presence and severity of postoperative cognitive impairment compared to preoperative
Time frame: One night 2 to 4 night preoperatively, and after the second postoperative night.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Background: PubMed 28187050Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
- Background: PubMed 24733193Inouye SK, Kosar CM, Tommet D, Schmitt EM, Puelle MR, Saczynski JS, Marcantonio ER, Jones RN. The CAM-S: development and validation of a new scoring system for delirium severity in 2 cohorts. Ann Intern Med. 2014 Apr 15;160(8):526-533. doi: 10.7326/M13-1927.
- Background: PubMed 697075Keats AS. The ASA classification of physical status--a recapitulation. Anesthesiology. 1978 Oct;49(4):233-6. doi: 10.1097/00000542-197810000-00001. No abstract available.
- Results publication: PubMed 20626359Krenk L, Rasmussen LS, Kehlet H. New insights into the pathophysiology of postoperative cognitive dysfunction. Acta Anaesthesiol Scand. 2010 Sep;54(8):951-6. doi: 10.1111/j.1399-6576.2010.02268.x. Epub 2010 Jul 12.
- Results publication: 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.
- Results publication: PubMed 22831887Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Nov;109(5):769-75. doi: 10.1093/bja/aes252. Epub 2012 Jul 24.
- Results publication: PubMed 24300462Riedel B, Browne K, Silbert B. Cerebral protection: inflammation, endothelial dysfunction, and postoperative cognitive dysfunction. Curr Opin Anaesthesiol. 2014 Feb;27(1):89-97. doi: 10.1097/ACO.0000000000000032.
- Results publication: PubMed 31011286Ni P, Dong H, Zhou Q, Wang Y, Sun M, Qian Y, Sun J. Preoperative Sleep Disturbance Exaggerates Surgery-Induced Neuroinflammation and Neuronal Damage in Aged Mice. Mediators Inflamm. 2019 Mar 18;2019:8301725. doi: 10.1155/2019/8301725. eCollection 2019.
- Results publication: PubMed 25355222He J, Hsuchou H, He Y, Kastin AJ, Wang Y, Pan W. Sleep restriction impairs blood-brain barrier function. J Neurosci. 2014 Oct 29;34(44):14697-706. doi: 10.1523/JNEUROSCI.2111-14.2014.
- Results publication: PubMed 30169703McMahon WR, Ftouni S, Drummond SPA, Maruff P, Lockley SW, Rajaratnam SMW, Anderson C. The wake maintenance zone shows task dependent changes in cognitive function following one night without sleep. Sleep. 2018 Oct 1;41(10). doi: 10.1093/sleep/zsy148.
- Results publication: PubMed 28666588de Raaff CAL, Gorter-Stam MAW, de Vries N, Sinha AC, Jaap Bonjer H, Chung F, Coblijn UK, Dahan A, van den Helder RS, Hilgevoord AAJ, Hillman DR, Margarson MP, Mattar SG, Mulier JP, Ravesloot MJL, Reiber BMM, van Rijswijk AS, Singh PM, Steenhuis R, Tenhagen M, Vanderveken OM, Verbraecken J, White DP, van der Wielen N, van Wagensveld BA. Perioperative management of obstructive sleep apnea in bariatric surgery: a consensus guideline. Surg Obes Relat Dis. 2017 Jul;13(7):1095-1109. doi: 10.1016/j.soard.2017.03.022. Epub 2017 Mar 30.
- Results publication: PubMed 23663938Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. No abstract available.
- Individual participant dataSharing planned: No
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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.
Henrik Kehlet, Dr.med,Phd study director
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 Sleep Disturbance and Delirium, run by Hvidovre University Hospital 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 5 inclusion and 6 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 18 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Garioud, MD (+4542705009, alexandre.garioud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in postoperative REM sleep time compared to preoperative (time frame: One night 2 to 4 night preoperatively, and the first and second postoperative night.). 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 NCT04227873, which also lists 16 linked publications.
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 18 Feb 2020.