Non-pharmacological Treatment of Insomnia in Nursing Homes.
Pilot Study on the Feasibility of Non-pharmacological Treatment of Insomnia in Nursing Homes.
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2010
CompletedFirst Posted
Study publicly available on registry
March 24, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 8, 2011
June 1, 2011
11 months
March 19, 2010
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
after 3 months
Secondary Outcomes (3)
Insomnia, as measured by the Groningen Sleep Quality Questionnaire
at baseline and after 3 months
quality of life
at baseline and after 3 months
Use of sleep medication
at baseline and after 3 months
Study Arms (1)
Non-pharmacological approach of insomnia
EXPERIMENTALNon-pharmacological approach of insomnia based on cognitive-behavioural techniques (education on sleep, sleep hygiene, stimulus control, cognitive techniques)
Interventions
education on sleep, sleep hygiene, stimulus control, cognitive techniques
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
- Flemish Minister for Welfare, Public Health and Family, Belgiumcollaborator
- Farmaka vzw, Belgiumcollaborator
- Domus Medica vzw, Belgiumcollaborator
Study Sites (1)
University Ghent
Ghent, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry Christiaens, MD, PhD
University Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 19, 2010
First Posted
March 24, 2010
Study Start
April 1, 2010
Primary Completion
March 1, 2011
Study Completion
June 1, 2011
Last Updated
June 8, 2011
Record last verified: 2011-06