The effects of a sleep robot intervention on sleep, depression and anxiety in adults with insomnia - Study protocol of a randomized waitlist-controlled trial.

Insomnia is a common sleep disorder characterized by difficulties initiating sleep, maintaining sleep and/or early-morning awakenings. Hyperarousal is a common causal and maintaining factor in insomnia models. Different techniques to decrease arousal have shown to be effective. Calm breathing can be one approach to enhance sleep. The Somnox sleep robot looks like a bean-shaped cushion to hug, and it gives physical and auditive guidance to calm down the users' breathing. There is currently no impartial empirical evidence of the sleep robot's effects on insomnia. This study is a randomized waitlist-controlled trial with a recruitment target of a minimum of 44 adults with insomnia and sleep disturbing arousal. Participants will complete pre-, mid- and post-intervention assessments, in addition to a 1-month follow-up. The primary outcome measure is the Insomnia Severity Index. Secondary sleep outcome measures are the Pre-Sleep Arousal Scale, a sleep diary and actigraphy. A secondary comorbid symptoms outcome measure is the Hospital Anxiety and Depression Scale. The main research question is whether treated participants have greater improvements regarding symptoms of insomnia post-intervention, compared with the waitlist control group. The analytic approach will be mixed-effects models. The current study will increase the knowledge on breath guidance as a way to reduce hyperarousal and enhance sleep. The sleep robot is a novel method and a potential treatment option for people with insomnia, when the recommended first-line treatments of Cognitive Behavioral Therapy and pharmaceuticals are inaccessible or undesirable. The ethics of healthcare robotics is discussed.