Novel Active-Feedback Device improves sleep quality in Insomnia Disorder: a randomized placebo-controlled trial

Objectives:

Insomnia disorder is a public health challenge associated with impaired cognitive functioning, reduced quality of life, and adverse mental health outcomes. This study examined the effectiveness of SleepCogni, an active-feedback device, in reducing insomnia symptom severity and improving perceived sleep quality in individuals with insomnia disorder.

Method:

A two-arm, parallel-group trial design was used, with 80 participants randomized to either the experimental group or the placebo control group. Participants provided self-reported measures of insomnia severity, sleep continuity, and user experience as main outcome variables.

Results:

Repeated measures analysis of variance showed that participants in the experimental group reported significantly greater improvements in insomnia symptom severity than the control group (Time × Treatment). Although the mean difference did not reach the threshold for clinical significance, 37.5% of the participants achieved this threshold within 1 week of treatment. Mixed-effects models showed significant improvements in sleep efficiency and total sleep time, based on sleep diary records. Finally, an independent samples t-test and content analysis indicated a more positive user experience in the experimental group.

Conclusion:

The SleepCogni device appears to be a useful tool for improving sleep outcomes in individuals with insomnia disorder, showing effects on both insomnia severity and subjectively evaluated sleep. The SleepCogni device presents a useful intervention that might be used alone or as a complement to increase the effectiveness of existing treatments, such as cognitive behavioral therapy for insomnia.