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Clinical Trials/NCT01091987
NCT01091987CompletedNot Applicable

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

University Ghent1 site in 1 country45 target enrollmentStarted: April 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
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.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts 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
  • •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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (1)

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