SleepNCT02953574
Daily Sleep Enhancement for Hospitalized People With Dementia Following a Nursing Protocol
A study testing daily sleep enhancement nursing protocol in people with Sleep and Dementia, run by University of Zurich.
Trial summary
The purpose of this study is to determine if the daily performance of a 7 step bedtime nursing protocol for hospitalized people living with dementia is feasible and if it has an effect on bedtime and daytime variables. Read more about this study
- Who is it for?
- Ages 70 years and older
- What is being tested?
- daily sleep enhancement nursing protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 3 Aug 2017
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- diagnosis of dementia of any severity and type
- Allocation to geriatric rehabilitation treatment
Who cannot join
- sleep related respiratory or moving related disorders or Parasomnia
- delirium
- end of life care
About this study
Official title: Daily Sleep Enhancement for Hospitalized People With Dementia Following a 7 Step Nursing Protocol: a Quasi-experimental Pilot Study
The purpose of this study is to determine if the daily performance of a 7 step bedtime nursing protocol for hospitalized people living with dementia is feasible and if it has an effect on bedtime and daytime variables.
- Being tested
- daily sleep enhancement nursing protocol
- Keywords
- geriatric nursing
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily sleep enhancement nursing protocolProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| daily sleep enhancement nursing protocol | Experimental | A 7 step nursing protocol. Each step is daily provided to the demented patient through a nurse by bedtime.
Step 1: serve a late snack Step 2: evening care (brush teeth, get pyjama on, go to toilette) Step 3: note and treat physical circumstances that restrain sleep (pain, obstipation,...) Step 4: ensure comfortable position abed Step 5: assist to eliminate stressful situation (calm, reorientating conversation) Step 6: turn off the light Step 7: care for a silent environment (turn off Television, radio and "do not disturb"-sign at the door) Receives: Procedure: daily sleep enhancement nursing protocol |
| usual nursing care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bedtime in minutes
Protocol of daily bedtime
Measured: Daily for up to 14 days from date of giving informed consent to hospital discharge
Secondary outcomes (6)
Sleeps through the night consistently, 5 point ordinal scale from "severe compromised" to "not compromised"
Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC)
Scale:
- severe compromised
- substantial compromised
- moderate compromised
- mild compromised
- not compromised
Measured: Every second day for up to 14 days from date of giving informed consent to hospital discharge
Inappropriate napping, 5 point ordinal scale ranging from "sever" to "none"
Subitem of the Outcome 'Sleep' from the Nursing Outcome Classification (NOC)
Scale:
- severe
- substantial
- moderate
- mild
- none
Measured: Every second day for up to 14 days from date of giving informed consent to hospital discharge
Cognitive performance (Mini-mental-status-test score)
Mini-mental-status-test score (range 0-30). Any score greater than or equal to 24 points (out of 30) indicates a normal cognition.
Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment
Measured: Once in first three days after giving informed consent and another time 7 or 14 days later
Physical performance measured with the Handgrip strength test
Handgrip strength in Pascal
Measured: Once in first three days after giving informed consent and another time 7 or 14 days later
Use of drugs promoting sleep (sedative neuroleptics, hypnotics, sedative antidepressant in the time between 18:00-24:00) (nominal variable: yes or no)
Medical charts review for sedative neuroleptics (e.g. Quetiapine, Haloperidol), sedative antidepressives (e.g. Trazodon), hypnotics present (Benzodiazepines, benzodiazepine-like drugs) in the time between 18:00-24:00 (nominal variable: yes or no )
Measured: day 1,2 and day 6,7 or 13,14
Medical chart review for discharge domicile after hospitalisation (nursing home, home, other institution, other)
Domicile after hospital discharge
Measured: day 7 or 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion3 Aug 2017
- Study completion3 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanna Burkhalter, Dr. sc. med., Principal investigator, Center of Sleep Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953574
- Sponsor's protocol ID
- 2016-00780
- Other IDs
- 2016
- Status last verified
- Aug 2017
- First submitted
- 20 Oct 2016
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Sleep Enhancement for Hospitalized People With Dementia Following a 7 Step Nursing Protocol: a Quasi-experimental Pilot Study
- ClinicalTrials.gov ID
- NCT02953574
- Acronym / sponsor ID
- 2016-00780
- Keywords
- geriatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 3 Nov 2016 (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 determine if the daily performance of a 7 step bedtime nursing protocol for hospitalized people living with dementia is feasible and if it has an effect on bedtime and daytime variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| daily sleep enhancement nursing protocol | Experimental | Procedure: daily sleep enhancement nursing protocolA 7 step nursing protocol. Each step is daily provided to the demented patient through a nurse by bedtime. Step 1: serve a late snack Step 2: evening care (brush teeth, get pyjama on, go to toilette) Step 3: note and treat physical circumstances that restrain sleep (pain, obstipation,...) Step 4: ensure comfortable position abed Step 5: assist to eliminate stressful situation (calm, reorientating conversation) Step 6: turn off the light Step 7: care for a silent environment (turn off Television, radio and "do not disturb"-sign at the door) |
| usual nursing care | No intervention | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- diagnosis of dementia of any severity and type
- Allocation to geriatric rehabilitation treatment
Key exclusion criteria (3 listed)
- sleep related respiratory or moving related disorders or Parasomnia
- delirium
- end of life care
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 |
|---|---|---|
| daily sleep enhancement nursing protocol | Procedure or surgery | daily sleep enhancement nursing protocol |
Primary outcome
Bedtime in minutes
Time frame: Daily for up to 14 days from date of giving informed consent to hospital discharge
Protocol of daily bedtime
6 secondary outcomes
Sleeps through the night consistently, 5 point ordinal scale from "severe compromised" to "not compromised"
Time frame: Every second day for up to 14 days from date of giving informed consent to hospital discharge
Inappropriate napping, 5 point ordinal scale ranging from "sever" to "none"
Time frame: Every second day for up to 14 days from date of giving informed consent to hospital discharge
Cognitive performance (Mini-mental-status-test score)
Time frame: Once in first three days after giving informed consent and another time 7 or 14 days later
Physical performance measured with the Handgrip strength test
Time frame: Once in first three days after giving informed consent and another time 7 or 14 days later
Use of drugs promoting sleep (sedative neuroleptics, hypnotics, sedative antidepressant in the time between 18:00-24:00) (nominal variable: yes or no)
Time frame: day 1,2 and day 6,7 or 13,14
Medical chart review for discharge domicile after hospitalisation (nursing home, home, other institution, other)
Time frame: day 7 or 14
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 8 Aug 2017.
- 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.
Hanna Burkhalter, Dr. sc. med. principal investigator
Center of Sleep Medicine
Questions about this trial
What is this clinical trial studying?
A study testing daily sleep enhancement nursing protocol in people with Sleep and Dementia, run by University of Zurich.
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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Bedtime in minutes (time frame: Daily for up to 14 days from date of giving informed consent to hospital discharge). 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 8 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.