Effectiveness of Physio Acoustic Sound (PAS) therapy in demented nursing home residents with nocturnal restlessness: study protocol for a randomized controlled trial

Trials

Rob A de Bie²  Jos MGA Schols¹  Dorus Schalkwijk³  Leelie Aziz³  Arnoldien J van Os³ 

[1] Department of General Practice and Department of Health Services Research, Caphri-School for Public Health and Primary Care, Maastricht, The Netherlands;Department of Epidemiology and Institute for Education, Caphri-School for Public Health and Primary Care, Maastricht, The Netherlands;Zorgspectrum Het Zand, Hollewandsweg 17, Zwolle 8014BE, The Netherlands

关键词: Nocturnal restlessness;    Nursing home;    Physio acoustic sound;    Actiwatch;    Sleep;    Dementia;   

Others  :  1095642
DOI  :  10.1186/1745-6215-13-34

 received in 2012-01-17, accepted in 2012-04-11,  发布年份 2012

【 摘 要 】

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.

Discussion

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.

Trial registration

Netherlands Trial Register (NTR): NTR3242

【 授权许可】

   
2012 van Os et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Ancoli-Israel S, Ayalon L: Diagnosis and treatment of sleep disorders in older adults. Am J Geriatr Psychiatry 2006, 14:95-103.
• [2]Anderson KN, Hatfield C, Kipps C, Hastings M, Hodges JR: Disrupted sleep and circadian patterns in frontotemporal dementia. Eur J Neurol 2009, 16:317-323.
• [3]Woensel-Kwast MA: Nachtelijke onrust bij ouderen, een (on)oplosbaar probleem? Medisch J 2002, 31:47-51.
• [4]Vugt ME, Stevens F, Aalten P, Lousberg R, Jaspers N, Verhey FRJ: A prospective study of the effects of behavioral symptoms on the institutionalization of patients with dementia. Int Psychogeriatr 2005, 17:577-589.
• [5]Kleijer BC, Marum RJ, Egberts AC, Jansen PA, Frijters D, Heerdink ER, Ribbe M: The course of behavioral problems in elderly nursing home patients with dementia when treated with antipsychotics. Int Psychogeriatr 2009, 21:931-940.
• [6]Ouslander JG, Cornell BR, Bliwise DL, Endeshaw Y, Griffiths P, Schnelle JF: A nonpharmacological intervention to improve sleep in nursing home patients: results of a controlled clinical trial. J Am Geriatr Soc 2006, 54:38-47.
• [7]Nordennen RTCM, Verhoeven A, Schots E: Probleemgedrag: insteken op niet-medicamenteuze behandeling. Tijdschrift voor Ouderengeneeskunde 2010, 35:91-94.
• [8]van der Lek Riemersma R, Swaab DF, Twisk J, Hol EM, Hoogendijk WJG, Van Someren EJW: Effect of bright light and melatonin on cognitive and non-cognitive function in elderly residents of group care facilities: a randomized controlled trial. JAMA 2008, 299:2642-2655.
• [9]Eggermont LHP, Blankevoort CG, Scherder JA: Walking and night-time restlessness in mild-to-moderate dementia: a randomized controlled trial. Age Ageing 2010, 39:746-761.
• [10]Alessi CA, Martin JL, Webber AP, Kim EC, Harker JO, Josephson KR: Randomized, controlled trial of nonpharmacological intervention to improve abnormal sleep/wake patterns in nursing home residents. J Am Geriatr Soc 2005, 53:803-810.
• [11]Lundqvist LO, Andersson G, Viding J: Effects of vibroacoustic music on challenging behaviours in individuals with autism and developmental disabilities. Research in Autism Spectrum Disorders 2009, 3:390-400.
• [12]Zheng A, Sakari R, Cheng SM, Hietikko A, Moilanen P, Timonen J, Fagerlund KM, Kärkäinen M, Alèn M, Cheng S: Effects of a low-frequency sound wave therapy programme on a functional capacity, blood circulation en bone metabolism in frail old men and women. Clin Rehabil 2009, 23:897-908.
• [13]Boyd-Brewer CB, McCaffrey R: Vibroacoustic sound therapy improves pain management and more. Holist Nurs Pract 2004, 18:111-118.
• [14]Mariauzouls C, Michel D, Schiftan Y: Vibration-assisted music therapy reduces pain and promotes relaxation of para- and tetraplegic patients. A pilot study of psychiatric and physical effects of simultaneous acoustic and somatosensory music stimulation as pain management. Rehabilitation 1999, 38:245-248.
• [15]King LK, Almeida QJ, Ahonen H: Short-term effects of vibration therapy on motor impairments in Parkinson's disease. NeuroRehabilitation 2009, 25:297-306.
• [16]Next Wave Ltd Physioacoustic [http://www.nextwave.fi/phtreatment.htm] webcite
• [17]Melzack R, Wall PD: Pain mechanism: a new theory. Science 1965, 150:971-979.
• [18]Someren EJW: Circadian and sleep disturbance in the eldery. Exp Gerontol 2000, 35:1229-1237.
• [19]Mills EJ, Chan AW, Wu P, Vail A, Guyatt GH, Altman GH: Design, analysis, and presentation of crossover trials. Trials 2009, 10:1-6. BioMed Central Full Text
• [20]Linn BS, Linn MW, Gurel L: Cumulative Illness Scale. J Am Geriatr Soc 1968, 16:622-626.
• [21]Bellelli G, Frisoni GB, Bianchetti A, Trabucchi M: The Bedford Alzheimer Nursing Severity Scale for the Severely Demented: Validation Study. Alzheimer Dis Assoc Disord 1997, 11:71-77.
• [22]Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcoft W, Pollak CP: The role of actigraphy in the study of sleep and circadian rhythms. Sleep 2005, 28:1017-1018.
• [23]Ancoli-Israel S, Vitiello MV: Sleep in dementia. Am J Geriatr Psychiatry 2006, 14:91-94.
• [24]Most EIS, Scheltens P, van Someren EJW: Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light - a randomized clinical trial. Trials 2010, 11:1-9. BioMed Central Full Text
• [25]van Wouwe NC, Valk PJ, Veenstra BJ: Sleep monitoring: a comparison between three wearable instruments. Military Medicin 2011, 176:811-816.
• [26]Otte JL, Payne JK, Carpenter JS: Nighttime variability in wrist actigraphy. J Nurs Meas 2011, 19:105-114.
• [27]Martin JL, Hakim AD: Wrist actigraphy. Chest 2011, 139:1514-1527.
• [28]Eggermont LHP, Scherder EJA: Ambulatory but sedentary: impact on cognition and the rest-activity rhythm in nursing home residents with dementia. J Gerontol B Psych Sci Soc Sci 2008, 63B:279-287.
• [29]Carvalho-Bos SS, van der Lek Riemersma RF, Waterhouse J, Reilly T, van Someren EJW: Strong association of the rest-activity rhythm with well-being in demented elderly women. Am J Geriatr Psychiatry 2007, 15:92-100.
• [30]Someren EJW: Improving actigraphic sleep estimates: how many nights? J Sleep Res 2007, 16:269-275.
• [31]Hoekert M, der Lek RF, Swaab DF, Kaufer D, Someren EJW: Comparison between informant-observed and actigraphic assessment of sleep-wake rhythm disturbances in demented residents of homes for elderly. Am J Geriatr Psychiatry 2006, 14:104-111.
• [32]de Jonghe JF, Borkent LM, Kat MG: Neuropsychiatrische vragenlijst: Verpleeghuis versie (NPI-NH). Nederlandse vertaling van: Neuropsychiatric Inventory - Nursing Home version, Cummings, JL; 1998.
• [33]Zuidema SU, Buursema AL, Gerritsen MG, Oosterwal KC, Smits MM, Koopmans RT, de Jonghe JF: Assessing neuropsychiatric symptoms in nursing home patients with dementia: Reliability and Reliable Change Index of the Neuropsychiatric Inventory and the Cohen-Mansfield Agitation Inventory. Int J Geriatr Psychiatry 2011, 26:127-134.
• [34]Field A: Discovering Statistics Using SPSS And Sex and Drugs and Rock 'n' Roll. London: Sage Publications Ltd; 2009.
• [35]Hox JJM: Multilevel analysis: Techniques and applications. Mahwah, NJ: Erlbaum; 2002.
• [36]Bliwise DL: Sleep disorders in Alzheimer's disease and other dementias. Clin Cornerstone 2004, 6:16-28.