Non-pharmacological Treatment of Insomnia in Nursing Homes.

This study has been completed.
Sponsor:
Collaborators:
Flemish Minister for Welfare, Public Health and Family, Belgium
Farmaka vzw, Belgium
Domus Medica vzw, Belgium
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT01091987
First received: March 19, 2010
Last updated: June 7, 2011
Last verified: June 2011
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: at baseline and after 3 months ] [ Designated as safety issue: No ]
    measured by the Geriatric Behaviour Observation Scale

  • Use of sleep medication [ Time Frame: at baseline and after 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thierry Christiaens, MD, PhD, University Ghent
ClinicalTrials.gov Identifier: NCT01091987     History of Changes
Other Study ID Numbers: 2010/031
Study First Received: March 19, 2010
Last Updated: June 7, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Ghent:
Insomnia

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

ClinicalTrials.gov processed this record on August 21, 2014