title: Effectiveness of Physio Acoustic Sound (PAS) therapy in demented nursing home residents with nocturnal restlessness: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Many older people with neuropsychiatric disorders such as Alzheimer's disease and frontotemporal dementia suffer from sleeping problems and often show nocturnal restlessness. Professionals and informal carers face considerable problems in solving these problems. Attempts to diminish these problems with medication in a safe and responsible manner have proven hardly effective or not effective at all. Therefore, nowadays the focus lies more on non-pharmacological solutions, for example by influencing environmental factors. There are indications that treatment with low-frequency acoustic vibrations, that is Physio Acoustic Sound (PAS) therapy, has a positive effect on sleeping problems. Therefore we study the effectiveness of PAS therapy in demented patients with nocturnal restlessness.
  
  
  METHODS
  In a randomized clinical trial, 66 nursing home patients will be divided into two groups: an intervention group and a control group. For both groups nocturnal restlessness will be measured with actiwatches during a period of six weeks. In addition, a sleep diary will be filled in.For the intervention group the baseline will be assessed, in the first two weeks, reflecting the existing situation regarding nocturnal restlessness. In the next two weeks, this group will sleep on a bed identical to their own, but with a mattress containing an in-built PAS device. As soon as the patient is lying in bed, the computer programme inducing the vibrations will be switched on for the duration of 30 min. In the last two weeks, the wash-out period, the measurements of the intervention group are continued, without the PAS intervention.During the total study period, other relevant data of all the implied patients will be recorded systematically and continuously, for example patient characteristics (data from patient files), the type and seriousness of the dementia, occurrence of neuropsychiatric symptoms during the research period, and the occurrence of intermittent co-morbidity.
  
  
  CONCLUSIONS
  If PAS therapy turns out to be effective, it can be of added value to the treatment of nocturnal restlessness in demented patients. Non-pharmacological PAS therapy is not only safe and patient-friendly, but it can also be widely used in a simple and relatively inexpensive way, both in institutions such as nursing homes and residential homes for the elderly, and at home. Ultimately, this may lead to a decrease in the frequent and still common use of psychotropic drugs. In addition, care needs of demented patients also may decrease as well as the number of preventable admissions to care institutions.
  
  
  BACKGROUND
  Netherlands Trial Register (NTR): NTR3242.
authors.affiliation: Zorgspectrum Het Zand, Hollewandsweg 17, Zwolle 8014BE, The Netherlands. a.vanos@hetzand.nl
authors.forename: Arnoldien J
authors.initials: AJ
authors.lastname: van Os
authors.forename: Leelie
authors.initials: L
authors.lastname: Aziz
authors.forename: Dorus
authors.initials: D
authors.lastname: Schalkwijk
authors.forename: Jos M G A
authors.initials: JM
authors.lastname: Schols
authors.forename: Rob A
authors.initials: RA
authors.lastname: de Bie
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D003625:Data Collection; D006801:Humans; D009735:Nursing Homes; D017063:Outcome Assessment, Health Care; D011595:Psychomotor Agitation / Q000628:therapy*; D018401:Sample Size; D012893:Sleep Wake Disorders / Q000628:therapy*; D013016:Sound