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Completed

NCT Number: NCT01091987

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-pharmacological approach of insomnia

Behavioral

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

Primary outcomes

  1. 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 outcomes

  1. Insomnia, as measured by the Groningen Sleep Quality Questionnaire

    Time frame: at baseline and after 3 months

  2. quality of life

    Time frame: at baseline and after 3 months

    measured by the Geriatric Behaviour Observation Scale

  3. Use of sleep medication

    Time frame: at baseline and after 3 months

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2010
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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