Evaluation of actigraphy and automated telephoned questionnaires to assess hypnotic effects in insomnia.

This study aimed to explore new methodologies in insomnia research, namely whether actigraphy was suitable to show hypnotic effects over weeks in insomnia, and to compare an automated method of questionnaire data collection with traditional methods. Thirty-eight insomniacs took part in a 5-week, double-blind, placebo-controlled study of the effects of 2 weeks of administration of temazepam 20 mg on sleep. Outcome measures were actigraphy and daily St Mary's Hospital Sleep Questionnaires (SMHSQ). Actigraphy was performed using Actiwatch (CNT) and analysed using both the automated Actiwatch sleep analysis software and non-parametric analysis of rest-activity rhythms. The questionnaires were administered as straightforward pencil-and-paper for half of the time and an automated telephoned system for the other half. The experimental paradigm allowed within-subject comparison of traditional and automated data collection, both on and off drug. Actigraphy showed a high degree of inter-subject variability but, nevertheless, some sleep variables (Fragmentation Index, Actual Sleep Time %) showed significant improvement during drug treatment, and Sleep Efficiency and Actual Sleep Time were significantly worsened during the first post-drug week. Nonparametric circadian rhythm analysis showed no significant effect. Subjective data from the SMHSQ showed significant drug effects and there was no significant difference in scores between the automated and pencil-and-paper methods; automated data collection was slightly more acceptable to patients and minimized data entry and management. Effect sizes using within-subject and between-subject comparisons were calculated for the subjective and objective measures to inform future studies

RCT Entities:   Population Interventions Outcomes