Insomnia, Primary Clinical Trial
Official title:
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial
Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating
insomnia disorder delivered by a training course.
Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia
symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week
8.
Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia
disorder recruited from the community will be randomized to ZTEx training or SHE groups in a
1: 1 ratio.
Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and
daytime impairment.
Interventions: Subjects in the ZTEx training group will attend two training lessons (2-hour
each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will
receive sleep hygiene education with the schedule and duration that are same to the ZTEx
training group.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include
sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and
Depression Scale, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension.
Acceptability and compliance of ZTEx will be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective and objective sleep
parameters will be examined using a mixed-effects model.
n/a
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