InsomniaNCT01091987
Non-pharmacological Treatment of Insomnia in Nursing Homes.
A study testing Non-pharmacological approach of insomnia in people with Insomnia, run by University Ghent at 1 site in Belgium.
Trial summary
The study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Non-pharmacological approach of insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2010to Jun 2011
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female nursing home residents of age 55+ with insomnia, defined as difficulty in getting to sleep, difficulty in staying asleep, early wakening, or non-restorative sleep
Who cannot join
- insufficient cognitive ability for self-reflection
- dementia
- insomnia caused by a medical disorder (hyperthyroidism, congestive heart failure, peripheral arterial disease, GORD, COPD/asthma, angina pectoris, benign prostatic hyperplasia, arthritis, other
- insomnia caused by medication
- substance misuse
- other sleep disorder: restless legs syndrome, periodic limb movement disorder, sleep apnoea, narcolepsy
- psychiatric disorder: psychotic or bipolar disorder in anamnesis, major depression present or more than 2 episodes in anamnesis
- short stay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Feasibility of Non-pharmacological Treatment of Insomnia in Nursing Homes.
The study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians.
- Conditions
- Insomnia
- Being tested
- Non-pharmacological approach of insomnia
- Keywords
- Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-pharmacological approach of insomniaBehavioural
education on sleep, sleep hygiene, stimulus control, cognitive techniques
| Study group | Role | What they receive |
|---|---|---|
| Non-pharmacological approach of insomnia | Experimental | Non-pharmacological approach of insomnia based on cognitive-behavioural techniques (education on sleep, sleep hygiene, stimulus control, cognitive techniques) Receives: Behavioral: Non-pharmacological approach of insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of eligible residents who accepted to participate in the non-pharmacological program and the proportion of eligible residents who completed the non-pharmacological program.
Evaluation takes place at the moment the program is ended according to the trained caregiver or maximally 3 months after the start of the program.
Measured: after 3 months
Secondary outcomes (3)
Insomnia, as measured by the Groningen Sleep Quality Questionnaire
Measured: at baseline and after 3 months
quality of life
measured by the Geriatric Behaviour Observation Scale
Measured: at baseline and after 3 months
Use of sleep medication
Measured: at baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish Minister for Welfare, Public Health and Family, Belgium, Farmaka vzw, Belgium, Domus Medica vzw, Belgium
- Investigators
- Thierry Christiaens, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091987
- Sponsor's protocol ID
- 2010/031
- Status last verified
- Jun 2011
- First submitted
- 19 Mar 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Feasibility of Non-pharmacological Treatment of Insomnia in Nursing Homes.
- ClinicalTrials.gov ID
- NCT01091987
- Acronym / sponsor ID
- 2010/031
- Conditions
- Insomnia
- Keywords
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Flemish Minister for Welfare, Public Health and Family, Belgium, Farmaka vzw, Belgium, Domus Medica vzw, Belgium
- Study start
- Apr 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Mar 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 study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-pharmacological approach of insomnia | Experimental | Behavioral: Non-pharmacological approach of insomniaNon-pharmacological approach of insomnia based on cognitive-behavioural techniques (education on sleep, sleep hygiene, stimulus control, cognitive techniques) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female nursing home residents of age 55+ with insomnia, defined as difficulty in getting to sleep, difficulty in staying asleep, early wakening, or non-restorative sleep
Key exclusion criteria (8 listed)
- insufficient cognitive ability for self-reflection
- dementia
- insomnia caused by a medical disorder (hyperthyroidism, congestive heart failure, peripheral arterial disease, GORD, COPD/asthma, angina pectoris, benign prostatic hyperplasia, arthritis, other
- insomnia caused by medication
- substance misuse
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 |
|---|---|---|
| Non-pharmacological approach of insomniaeducation on sleep, sleep hygiene, stimulus control, cognitive techniques | Behavioural | Non-pharmacological approach of insomnia |
Primary outcome
The proportion of eligible residents who accepted to participate in the non-pharmacological program and the proportion of eligible residents who completed the non-pharmacological program.
Time frame: after 3 months
Evaluation takes place at the moment the program is ended according to the trained caregiver or maximally 3 months after the start of the program.
3 secondary outcomes
Insomnia, as measured by the Groningen Sleep Quality Questionnaire
Time frame: at baseline and after 3 months
quality of life
Time frame: at baseline and after 3 months
Use of sleep medication
Time frame: at baseline and after 3 months
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 Jun 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.
Thierry Christiaens, MD, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-pharmacological approach of insomnia in people with Insomnia, run by University Ghent at 1 site in Belgium.
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 1 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: finished, as of the sponsor's last update on 8 Jun 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 Belgium. 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?
The proportion of eligible residents who accepted to participate in the non-pharmacological program and the proportion of eligible residents who completed the non-pharmacological program. (time frame: after 3 months). 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 Jun 2011.