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Non-pharmacological Treatment of Insomnia in Nursing Homes.

Pilot Study on the Feasibility of Non-pharmacological Treatment of Insomnia in Nursing Homes.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01091987
Enrollment
45
Registered
2010-03-24
Start date
2010-04-30
Completion date
2011-06-30
Last updated
2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Insomnia

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.

Interventions

BEHAVIORALNon-pharmacological approach of insomnia

education on sleep, sleep hygiene, stimulus control, cognitive techniques

Sponsors

Flemish Minister for Welfare, Public Health and Family, Belgium
CollaboratorUNKNOWN
Farmaka vzw, Belgium
CollaboratorUNKNOWN
Domus Medica vzw, Belgium
CollaboratorUNKNOWN
University Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.after 3 monthsEvaluation 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

MeasureTime frameDescription
Insomnia, as measured by the Groningen Sleep Quality Questionnaireat baseline and after 3 months
quality of lifeat baseline and after 3 monthsmeasured by the Geriatric Behaviour Observation Scale
Use of sleep medicationat baseline and after 3 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026