Sleep ArchitectureNCT02302560
Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)
An observational study of Sleep Architecture, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this prospective observational study is to investigate the changes in sleep architecture after a hip surgery and its potential association with postoperative delirium and postoperative cognitive dysfunctions respectively. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sleep Architecture
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Nov 2019
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with elective hip surgery (implementation or replacement of hip joint endoprothesis)
Who may be able to join
- Male and female patients with age 50 years and above
- Intervention for hip joint endoprosthesis or replacement of endoprosthesis at the Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum, Charité - University Medicine Berlin
Who cannot join
- Lacking willingness to save and hand out data within the study
- Missing informed consent of the patient
- Participation in other prospective interventional study 10 days before study inclusion and during the study period
- Patients with diagnosed and treated sleep disorders
- Patients with psychiatric diseases
- Patients with injuries or operations of the enteral tract and the esophagus respectively in the last four weeks before the hip surgery
- Allergies to any substance of the electrode fixing material
- Dermatoses in the area of the electrodes to be fixed
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine Berlin
Berlin, 13353
About this study
The purpose of this prospective observational study is to investigate the changes in sleep architecture after a hip surgery and its potential association with postoperative delirium and postoperative cognitive dysfunctions respectively.
Read the detailed description
Sleep research has confirmed the association of sleep (REM sleep and slow-wave sleep) with memory and cognitive function in general. There are changes in the quantity of REM sleep after certain forms of anesthesia, especially with barbiturate, as shown in mouse model. This study is designed to be the first explorative clinical studyl to measure changes in sleep architecture in surgical patients undergoing different types of anesthesia (general anesthesia and spinal anesthesia) and its potential associations with the development of postoperative delirium and postoperative cognitive dysfunction. Additionally, parameters will be collected, that from recent research are suspected to be reliable markers for systemic inflammation that might account for delirium and cognitive dysfunction after surgical interventions.
Patients were stratified into two groups: age (≤ 65 years; > 65 years) and benzodiazepine premedication (yes/no).
- Conditions
- Sleep Architecture
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 |
|---|---|---|
| Patients with elective hip surgery | Patients with elective hip surgery (implementation or replacement of hip joint endoprotheses). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in prevalence of rapid eye movement sleep
Changes in prevalence of rapid eye movement (REM) sleep in the preoperative night compared to the night following the first postoperative day, including potentially compensatory sleep during daytime after surgery.
Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 36 h (beginning in the preoperative evening, to be finished the morning of the second postoperative day).
Measured: Up to 36 hours
Secondary outcomes (18)
Insomnia Severity Index
The ISI will be assessed by self-assessment questionnaire
Measured: Up to 90 days after the operation
Malnutrition
Malnutrition Screening Tools
Measured: Up to 90 days after the operation
Epsworth Sleepiness Scale
The ESS will be assessed by self-assessment questionnaire
Measured: Up to 90 days after the operation
Postoperative Cognitive Dysfunction
Postoperative Cognitive Dysfunction will be measured at hospital discharge and at the 90th postoperative day.
Measured: Up to 90 days after the operation
Depth of anesthesia
Depth of anesthesia will be measured by processive Electroencephalography and Electromyography (EEG/EMG) -Data (SedLine®)
Measured: At time of surgery
Opioid requirements
Postoperative pain will be measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI)
Measured: Participants will be followed up for hospital stay an expected average of 7 days
Length of hospital stay
Measured: Participants will be followed up for hospital stay an expected average of 7 days
Pain
Postoperative pain will be measured by Numeric Rating Scale - Visualized (NRS-V), the Faces Pain Scale - Revised (FPS-R), the Behavioral Pain Scale (BPS) or the Behavioral Pain Scale for Non-Intubated (BPS-NI)
Measured: Participants will be followed up for hospital stay an expected average of 7 days
N-Methyl-D-aspartate (NMDA)-receptor autologous antibodies
Identification of NMDA-receptor autologous antibodies in blood serum and cerebrospinal fluid; the requested blood samples will be collected on the operation day, on the last day of hospitalisation and after 90 days. The requested liquor samples will be collected on the operation day (only in patients with spinal anesthesia).
Measured: Up to 90 days after the operation
Inflammation parameters
Assessment of inflammation parameters by means of extended differential blood count (Sysmex) ; the requested blood samples will be collected on the preoperative day, on the day of the intervention, on the following day and on the last day of the hospitalisation
Measured: Participants will be followed up for hospital stay an expected average of 7 days
Hemodynamic parameters
Hemodynamic variables are assessed by the anesthesia monitor and esophageal Doppler Monitor
Measured: At time of surgery
Changes in prevalence of rapid eye movement sleep
REM-Sleep at operation day/night in comparison to preoperative night. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 24 h.
Measured: Up to 24 hours
Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep)
Slow wave sleep at operation day/night in comparison to preoperative night. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 24 h.
Measured: Up to 24 hours
Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep)
Changes in prevalence of slow-wave sleep in the preoperative night compared to the night following the first postoperative day, including potentially compensatory sleep during daytime after surgery.
Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 36 h (beginning in the preoperative evening, to be finished the morning of the second postoperative day).
Measured: Up to 36 hours
Postoperative complications
Including Severity of Delirium
Measured: Participants will be followed up for hospital stay an expected average of 7 days
Transfusion requirements
Measured: Participants will be followed up for hospital stay an expected average of 7 days
Catecholamine administration intra- und postoperative
Measured: Participants will be followed up for hospital stay an expected average of 7 days
Severity of postoperative Delirium
Delirium screening will be conducted preoperatively, one hour postoperative, the evening of operation day, and the following morning with the scoring devices of confusion assessment method (CAM), by confusion assessment method in the intensive care unit (CAM-ICU) or by Nursing Delirium Screening Scale (Nu-DESC)
Measured: Up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ArchitectureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302560
- Sponsor's protocol ID
- TepSo
- Status last verified
- Apr 2018
- First submitted
- 7 Nov 2014
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Sleep Architecture in Patients With Hip Surgery (TepSo)
- ClinicalTrials.gov ID
- NCT02302560
- Acronym / sponsor ID
- TepSo
- Conditions
- Sleep Architecture
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 27 Nov 2014 (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 prospective observational study is to investigate the changes in sleep architecture after a hip surgery and its potential association with postoperative delirium and postoperative cognitive dysfunctions respectively.
Detailed description
Sleep research has confirmed the association of sleep (REM sleep and slow-wave sleep) with memory and cognitive function in general. There are changes in the quantity of REM sleep after certain forms of anesthesia, especially with barbiturate, as shown in mouse model. This study is designed to be the first explorative clinical studyl to measure changes in sleep architecture in surgical patients undergoing different types of anesthesia (general anesthesia and spinal anesthesia) and its potential associations with the development of postoperative delirium and postoperative cognitive dysfunction. Additionally, parameters will be collected, that from recent research are suspected to be reliable markers for systemic inflammation that might account for delirium and cognitive dysfunction after surgical interventions.
Patients were stratified into two groups: age (≤ 65 years; > 65 years) and benzodiazepine premedication (yes/no).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with elective hip surgery | – | –Patients with elective hip surgery (implementation or replacement of hip joint endoprotheses). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with elective hip surgery (implementation or replacement of hip joint endoprothesis)
Key inclusion criteria (2 listed)
- Male and female patients with age 50 years and above
- Intervention for hip joint endoprosthesis or replacement of endoprosthesis at the Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum, Charité - University Medicine Berlin
Key exclusion criteria (8 listed)
- Lacking willingness to save and hand out data within the study
- Missing informed consent of the patient
- Participation in other prospective interventional study 10 days before study inclusion and during the study period
- Patients with diagnosed and treated sleep disorders
- Patients with psychiatric diseases
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 prevalence of rapid eye movement sleep
Time frame: Up to 36 hours
Changes in prevalence of rapid eye movement (REM) sleep in the preoperative night compared to the night following the first postoperative day, including potentially compensatory sleep during daytime after surgery. Sleep architecture will be measured with the Somnoscreen device for mobile polysomnography for a total time duration of 36 h (beginning in the preoperative evening, to be finished the morning of the second postoperative day).
18 secondary outcomes
Insomnia Severity Index
Time frame: Up to 90 days after the operation
Malnutrition
Time frame: Up to 90 days after the operation
Epsworth Sleepiness Scale
Time frame: Up to 90 days after the operation
Postoperative Cognitive Dysfunction
Time frame: Up to 90 days after the operation
Depth of anesthesia
Time frame: At time of surgery
Opioid requirements
Time frame: Participants will be followed up for hospital stay an expected average of 7 days
Length of hospital stay
Time frame: Participants will be followed up for hospital stay an expected average of 7 days
Pain
Time frame: Participants will be followed up for hospital stay an expected average of 7 days
N-Methyl-D-aspartate (NMDA)-receptor autologous antibodies
Time frame: Up to 90 days after the operation
Inflammation parameters
Time frame: Participants will be followed up for hospital stay an expected average of 7 days
Hemodynamic parameters
Time frame: At time of surgery
Changes in prevalence of rapid eye movement sleep
Time frame: Up to 24 hours
Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep)
Time frame: Up to 24 hours
Changes in prevalence of slow-wave sleep (Stadium 3 of non rapid eye movement-sleep)
Time frame: Up to 36 hours
Postoperative complications
Time frame: Participants will be followed up for hospital stay an expected average of 7 days
Transfusion requirements
Time frame: Participants will be followed up for hospital stay an expected average of 7 days
Catecholamine administration intra- und postoperative
Time frame: Participants will be followed up for hospital stay an expected average of 7 days
Severity of postoperative Delirium
Time frame: Up to 36 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
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 Architecture, run by Charite University, Berlin, Germany at 1 site in Germany.
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 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: withdrawn, as of the sponsor's last update on 18 Apr 2018. 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 Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in prevalence of rapid eye movement sleep (time frame: Up to 36 hours). 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 18 Apr 2018.