Back to resultsNon-pharmacological Treatment of Insomnia in Nursing Homes.
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Non-pharmacological approach of insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-pharmacological approach of insomnia
Arm Description
Non-pharmacological approach of insomnia based on cognitive-behavioural techniques (education on sleep, sleep hygiene, stimulus control, cognitive techniques)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Insomnia, as measured by the Groningen Sleep Quality Questionnaire
quality of life
measured by the Geriatric Behaviour Observation Scale
Use of sleep medication
Full Information
NCT ID
NCT01091987
First Posted
March 19, 2010
Last Updated
June 7, 2011
Sponsor
University Ghent
Collaborators
Flemish Minister for Welfare, Public Health and Family, Belgium, Farmaka vzw, Belgium, Domus Medica vzw, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT01091987
Brief Title
Non-pharmacological Treatment of Insomnia in Nursing Homes.
Official Title
Pilot Study on the Feasibility of Non-pharmacological Treatment of Insomnia in Nursing Homes.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Ghent
Collaborators
Flemish Minister for Welfare, Public Health and Family, Belgium, Farmaka vzw, Belgium, Domus Medica vzw, Belgium
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-pharmacological approach of insomnia
Arm Type
Experimental
Arm Description
Non-pharmacological approach of insomnia based on cognitive-behavioural techniques (education on sleep, sleep hygiene, stimulus control, cognitive techniques)
Intervention Type
Behavioral
Intervention Name(s)
Non-pharmacological approach of insomnia
Intervention Description
education on sleep, sleep hygiene, stimulus control, cognitive techniques
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
after 3 months
Secondary Outcome Measure Information:
Title
Insomnia, as measured by the Groningen Sleep Quality Questionnaire
Time Frame
at baseline and after 3 months
Title
quality of life
Description
measured by the Geriatric Behaviour Observation Scale
Time Frame
at baseline and after 3 months
Title
Use of sleep medication
Time Frame
at baseline and after 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Christiaens, MD, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Ghent
City
Ghent
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Non-pharmacological Treatment of Insomnia in Nursing Homes.
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