Non-pharmacological Treatment of Insomnia in Nursing Homes.

June 7, 2011 updated by: University Ghent

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • University Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-pharmacological approach of insomnia
Non-pharmacological approach of insomnia based on cognitive-behavioural techniques (education on sleep, sleep hygiene, stimulus control, cognitive techniques)
Behavioral: Non-pharmacological approach of insomnia
education on sleep, sleep hygiene, stimulus control, cognitive techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia, as measured by the Groningen Sleep Quality Questionnaire
Time Frame: at baseline and after 3 months
at baseline and after 3 months
quality of life
Time Frame: at baseline and after 3 months
measured by the Geriatric Behaviour Observation Scale
at baseline and after 3 months
Use of sleep medication
Time Frame: at baseline and after 3 months
at baseline and after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

Flemish Minister for Welfare, Public Health and Family, Belgium
Farmaka vzw, Belgium
Domus Medica vzw, Belgium

Investigators

  • Principal Investigator: Thierry Christiaens, MD, PhD, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 19, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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