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

Recruiting

• Conditions: Demented nursing home residents with nocturnal restlessness.

• Registration Number: NL-OMON20663
• Lead Sponsor: Maastricht University, PO Box 616, 6200MD Maastricht , the Netherlands

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 66

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

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.;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.