Non-pharmacological Treatment of Insomnia in Nursing Homes.

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091987
• Other study ID #: 2010/031
• Status: Completed
• Phase: N/A
• First received: March 19, 2010
• Last updated: June 7, 2011
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Non-pharmacological approach of insomnia
education on sleep, sleep hygiene, stimulus control, cognitive techniques

Locations

Country	Name	City	State
Belgium	University Ghent	Ghent

Sponsors (4)

Lead Sponsor	Collaborator
University Ghent	Domus Medica vzw, Belgium, Farmaka vzw, Belgium, Flemish Minister for Welfare, Public Health and Family, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Secondary	Insomnia, as measured by the Groningen Sleep Quality Questionnaire		at baseline and after 3 months	No
Secondary	quality of life	measured by the Geriatric Behaviour Observation Scale	at baseline and after 3 months	No
Secondary	Use of sleep medication		at baseline and after 3 months	No