Non-pharmacological Treatment of Insomnia in Nursing Homes.

NCT ID: NCT01091987

Last Updated: 2011-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-pharmacological approach of insomnia

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

Group Type EXPERIMENTAL

Non-pharmacological approach of insomnia

Intervention Type BEHAVIORAL

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

Interventions

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Non-pharmacological approach of insomnia

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flemish Minister for Welfare, Public Health and Family, Belgium

UNKNOWN

Sponsor Role collaborator

Farmaka vzw, Belgium

UNKNOWN

Sponsor Role collaborator

Domus Medica vzw, Belgium

UNKNOWN

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Ghent

Principal Investigators

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Thierry Christiaens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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University Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2010/031

Identifier Type: -

Identifier Source: org_study_id

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