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Non-pharmacological Treatment of Insomnia in Nursing Homes.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01091987
First Posted: March 24, 2010
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Flemish Minister for Welfare, Public Health and Family, Belgium
Farmaka vzw, Belgium
Domus Medica vzw, Belgium
Information provided by:
University Ghent
  Purpose
The study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians.

Condition Intervention
Insomnia Behavioral: Non-pharmacological approach of insomnia

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on the Feasibility of Non-pharmacological Treatment of Insomnia in Nursing Homes.

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Insomnia, as measured by the Groningen Sleep Quality Questionnaire [ Time Frame: at baseline and after 3 months ]
  • quality of life [ Time Frame: at baseline and after 3 months ]
    measured by the Geriatric Behaviour Observation Scale

  • Use of sleep medication [ Time Frame: at baseline and after 3 months ]

Estimated Enrollment: 45
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091987


Locations
Belgium
University Ghent
Ghent, Belgium
Sponsors and Collaborators
University Ghent
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
  More Information

Responsible Party: Thierry Christiaens, MD, PhD, University Ghent
ClinicalTrials.gov Identifier: NCT01091987     History of Changes
Other Study ID Numbers: 2010/031
First Submitted: March 19, 2010
First Posted: March 24, 2010
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by University Ghent:
Insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders