SHODEN, 02 Jun 2018

Abhijit Deshpande, MD, Nushafreen Irani, MSc, Rathna Balakrishnan, MD

Abstract: Nonrestorative sleep (NRS) is one of the cardinal symptoms of insomnia and can occur independent of other components of insomnia. Among the sleep disturbances, NRS has been little studied in the general population, even though this symptom plays an important role in several medical conditions associated with chronic inflammation such as heart disease, fibromyalgia, and chronic fatigue syndrome, as well as various sleep disorders. There is paucity in the literature about effective treatments for NRS. Ashwagandha (Withania somnifera) has been demonstrated to reduce anxiety and stress, allowing the body to settle down and prepare for sleep. This study will be a double-blind, randomized, placebo-controlled interventional study in NRS population.

Method: Group-sequential method will be used to determine the sample size. The planned sample size of 150 subjects (75 in each study treatment group) will be required to detect a difference of 10 points in change in RSQ-W total score at 6 weeks from the baseline between the study treatment groups, assuming a standard deviation of 25 points and a 15% drop-out rate, to achieve 80% statistical power at 5% (2-sided) level of significance. Two interim analyses are planned to occur after completion of the study of 50 subjects and 150 subjects. If the analysis turns out to have a statistically non-significant difference, then the enrollment may extend to 236 subjects. The final analysis will be performed when all 236 subjects complete the study.

Conclusion: NRS is relatively common and yet underexplored issue. There is a paucity of knowledge about its prevalence, clinical implications, and treatment. This study will be the first of epidemiological studies to explore the prevalence of this entity in Indian population. To our knowledge, this will be the first study to explore objective correlates of NRS using actigraphy, which gives us the advantage of measuring these in subject’s own environment. Ashwagandha has been shown to be a useful supplement in many conditions such as postchemotherapy fatigue in double-blind, randomized studies. This study will also be the first to explore specific changes in sleep quality.