CLINICAL TRIAL article
Front. Sleep
Sec. Insomnia
Volume 4 - 2025 | doi: 10.3389/frsle.2025.1452213
This article is part of the Research TopicMethods to Modulate Sleep with Neurotechnology, Devices, or WearablesView all 5 articles
Novel Active-Feedback Device improves sleep quality in Insomnia Disorder: a randomized placebo-controlled trial
Provisionally accepted
- 1Sheffield Hallam University, Sheffield, United Kingdom
- 2Independent researcher, Sheffield, United Kingdom
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Objectives: Insomnia Disorder represents a public health challenge and is associated with impaired cognitive functioning and 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 among people with Insomnia Disorder. Method: A two-arm parallel group trial design was used, with 80 participants randomized to either the experimental or the placebo control group. Participants self-reported measures of insomnia severity, sleep continuity, and user experience, as main outcome variables. Results: Repeated measures ANOVA showed that experimental group participants reported significantly greater improvement in insomnia symptom severity, as compared to the control group (Time x Treatment). This mean difference did not reach a clinically meaningful improvement, but 37.5% of the participants reached this threshold within the one week of treatment. Mixed models showed significant improvements in sleep efficiency and total sleep time, based on sleep diary records. Finally, independent samples t-test and content analysis indicated more positive user experience in the experimental group. Conclusions: The SleepCogni device appears useful in improving sleep outcomes in people with Insomnia Disorder, as it changes 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. Trial registration: https://doi.org/10.17605/OSF.IO/RSWCB
Keywords: Sleep, insomnia, Treatment, Insomnia Severity Index, Consensus Sleep Diary, Sleep efficiency
Received: 20 Jun 2024; Accepted: 29 Apr 2025.
Copyright: © 2025 Ypsilanti, Van De Werken, Robson, Examilioti and Lazuras. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Antonia Ypsilanti, Sheffield Hallam University, Sheffield, United Kingdom
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.