A pilot randomized controlled trial of sleep therapy in Parkinson's disease: effect on patients and caregivers.
OBJECTIVE
By means of a controlled trial, to investigate the efficacy, tolerability and feasibility of a multi-component sleep therapy intervention versus basic sleep hygiene education in PD patients with sleep disturbances and their live-in carers.


METHODS
Patient-carer dyads were randomised to either of the two interventions. Quantitative measures of sleep, psychiatric and overall functioning were administered at baseline and two weeks after the intervention to patients and carers.


RESULTS
Sleep disturbances in the PD patients improved significantly in both the groups. Between group comparisons in both carers and patients revealed no significant differences on any outcome measures. The intervention was found to be well tolerated, feasible and could easily be translated into the clinical setting.


CONCLUSIONS
This pilot study makes the case for further, more rigorous study of pragmatic, non-pharmacological interventions for sleep disturbances in PD.
Leroi
Iracema
I
North Manchester General Hospital, Delaunays Rd, Manchester, UK. ileroi2002@yahoo.co.uk
Baker
Peter
P
Kehoe
Pam
P
Daniel
Emily
E
Byrne
E Jane
EJ
D000368:Aged; D000369:Aged, 80 and over; D017028:Caregivers / Q000523:psychology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D010300:Parkinson Disease / Q000150:complications / Q000628:therapy*; D017060:Patient Satisfaction; D010865:Pilot Projects; D012890:Sleep / Q000502:physiology*; D012893:Sleep Wake Disorders / Q000209:etiology / Q000628:therapy*; D013997:Time Factors