Non-pharmacological Treatment of Insomnia in Nursing Homes.

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Non-pharmacological approach of insomnia

• Registration Number: NCT01091987
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-22
• Study First Posted: 2010-03-24
• Study Start: 2010-04
• Primary Completion: 2011-03
• Status Verified: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-pharmacological approach of insomnia	Non-pharmacological approach of insomnia	Non-pharmacological approach of insomnia based on cognitive-behavioural techniques (education on sleep, sleep hygiene, stimulus control, cognitive techniques)

Primary Outcome Measures

Name	Time	Method
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 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 Outcome Measures

Name	Time	Method
Insomnia, as measured by the Groningen Sleep Quality Questionnaire	at baseline and after 3 months
quality of life	at baseline and after 3 months	measured by the Geriatric Behaviour Observation Scale
Use of sleep medication	at baseline and after 3 months

Trial Locations

Locations (1)

University Ghent; 🇧🇪 Ghent, Belgium