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Effectiveness of Physio Acoustic Sound (PAS) therapy in demented nursing home residents with nocturnal restlessness: A randomized clinical trial.

Effectiveness of Physio Acoustic Sound (PAS) therapy in demented nursing home residents with nocturnal restlessness: A randomized clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20663
Enrollment
66
Registered
2012-01-17
Start date
2011-07-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Demented nursing home residents with nocturnal restlessness.

Interventions

Patients will be randomized over an intervention group and a control group. The patients in the control group will sleep on their own high dependency bed during the three periods of two weeks each. Th

Sponsors

Maastricht University, PO Box 616, 6200MD Maastricht , the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients are included when diagnosed with the DSM-IV definition of dementia and who have been residing in the nursing home for a minimum of two months.

Exclusion criteria

Exclusion criteria: 1. The presence of a (high risk of) a pressure sore, i.e. an indication for the preventive use of a different mattress, e.g. an alternative mattress to prevent pressure ulcers; 2. Acute illness, e.g. pneumonia, exacerbation of heart failure, a recent stroke, etc.; 3. A pacemaker, which could possibly interfere with the PAS instruments.

Design outcomes

Primary

MeasureTime frame
The objectively and subjectively measured difference in nocturnal restlessness between T0-T1-T2. Objectively: The nocturnal restlessness measured during 6 weeks by means of an actiwatch validated for sleep research with the sleep/wake parameters mentioned above. Subjectively: Nocturnal restlessness determined on the basis of a sleep diary developed for this study, and filled in by the nursing staff.

Secondary

MeasureTime frame
The secondary outcome measure in this study involves an analysis of the prevalence and the degree of change in overall neuropsychiatric symptoms of the nursing home patients taking part in the study.

Contacts

Public ContactA.J. Os, van

Hollewandsweg 17

a.vanos@hetzand.nl+31 (0)38 4687741

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)