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

March 19, 2010
June 7, 2011
April 2010
March 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01091987 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Insomnia, as measured by the Groningen Sleep Quality Questionnaire [ Time Frame: at baseline and after 9 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: at baseline and after 9 months ] [ Designated as safety issue: No ]
    measured by the Geriatric Behaviour Observation Scale
  • Use of sleep medication [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Non-pharmacological Treatment of Insomnia in Nursing Homes.
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Insomnia
Behavioral: Non-pharmacological approach of insomnia
education on sleep, sleep hygiene, stimulus control, cognitive techniques
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)
Intervention: Behavioral: Non-pharmacological approach of insomnia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
June 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01091987
2010/031
No
Thierry Christiaens, MD, PhD, University Ghent
University Ghent
  • Flemish Minister for Welfare, Public Health and Family, Belgium
  • Farmaka vzw, Belgium
  • Domus Medica vzw, Belgium
Principal Investigator: Thierry Christiaens, MD, PhD University Ghent
University Ghent
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP