Protocol for single case experimental design for yoga and sleep quality and inflammation: A two-hit model of sleep intervention.

Background: Poor sleep quality is a neglected clinical condition in the elderly that could predispose them to morbidities and even mortality. Several lines of clinical evidence support the potential of Meditative Movement Interventions (MMIs) in the alleviation of sleep-related disturbances in the elderly population. However, further studies are needed to provide more definitive evidence regarding the effectiveness of yoga-based MMI.

Objective: The primary objective of this study is to evaluate the effectiveness of a repeated course of a yoga-based meditative intervention in a home environment to improve the sleep quality of elderly subjects.

Method: A single-case experimental design with multiple baselines will be used to assess the effectiveness of Yoga-based meditative movement as an intervention for the alleviation of poor sleep quality in the elderly. A concomitant study will also be conducted to test the effectiveness of walking as an intervention using the identical design. We will recruit 6 participants with self-rated poor sleep quality (PSQI>) with external validation using actigraphy. Each participant will be randomly allocated to a different baseline phase (i.e., 7, 10, or 14 days), which will then be followed by a daily 45-min intervention over 12 weeks. The walking group will undergo daily walking.

Conclusion: This single-case, multiple-baseline, between-case intervention randomization design will be the first report, wherein yoga-based intervention would be longitudinally monitored for changes in the objective measure of sleep quality.

Trial Registration: The registration number for this trial is CTRI/2021/02/031466.