Trial reportSleep2023
Does providing feedback and guidance on sleep perceptions using sleep wearables improve insomnia? Findings from "Novel Insomnia Treatment Experiment": a randomized controlled trial.
Trial report in Sleep, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- Effectiveness of Wearable Digital Therapeutics in Improving Sleep Outcomes Among Individuals With Insomnia: Systematic Review and Meta-Analysis of Randomized Controlled Trials.Journal of medical Internet research · 2026Pooled it
- Intensive Sleep Retraining and Total Sleep Deprivation for Treating Chronic Insomnia: A Randomised Controlled Trial.Journal of sleep research · 2026Trial
- Adjunctive smart ring monitoring during digital cognitive behavioral therapy for insomnia.Scientific reports · 2025Trial
- Perfectionism Contributes to Sleep-Wake State Discrepancy: The Mediating Role of Pre-Sleep Arousal.Brain sciences · 2026Article
- Clocking immunity: circadian modulation of NK cells and emerging timing perspectives.Frontiers in immunology · 2026Review
- Wearables as Translational Physiomarkers and Clinical Endpoints in Insomnia Research: Can Sleep Research Advance Psychiatry?Journal of sleep research · 2025Review
- Digital therapeutics for insomnia: an umbrella review and meta-meta-analysis.NPJ digital medicine · 2025Article
- Personalized EEG-guided brain stimulation targeting in major depression via network controllability and multi-objective optimization.BMC psychiatry · 2025Article
- Sleep disorders in cancer: interactions and intrinsic links.Frontiers in oncology · 2025Review
- From Pulses to Sleep Stages: Towards Optimized Sleep Classification Using Heart-Rate Variability.Sensors (Basel, Switzerland) · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesInsomnia is a disorder diagnosed based on self-reported sleep complaints. Differences between self-reported and sensor-based sleep parameters (sleep-wake state discrepancy) are common but not well-understood in individuals with insomnia. This two-arm, parallel-group, single-blind, superiority randomized-controlled trial examined whether monitoring sleep using wearable devices and providing support for interpretation of sensor-based sleep data improved insomnia symptoms or impacted sleep-wake state discrepancy.
methodsA total of 113 (age M = 47.53; SD = 14.37, 64.9% female) individuals with significant insomnia symptoms (Insomnia Severity Index(ISI) ≥10) from the community were randomized 1:1 (permuted block randomization) to receive 5 weeks (1) Intervention (n = 57): feedback about sensor-based sleep (Fitbit and EEG headband) with guidance for data interpretation and ongoing monitoring, and (2) Control (n = 56): sleep education and hygiene. Both groups received one individual session and two check-in calls. The ISI (primary outcome), sleep disturbance (SDis), sleep-related impairment (SRI), depression, and anxiety were assessed at baseline and post-intervention.
resultsIn total, 103 (91.2%) participants completed the study. Intention-to-treat multiple regression with multiple imputations showed that after controlling for baseline values, compared to the Control group (n = 51), the Intervention group (n = 52) had lower ISI (p = .011, d = 0.51) and SDis (p = .036, d = 0.42) post-intervention, but differences in SRI, depression, anxiety, and sleep-wake state discrepancy parameters (total sleep time, sleep onset latency, and wake after sleep onset) were not meaningful (P-values >.40).
conclusionsProviding feedback and guidance about sensor-based sleep parameters reduced insomnia severity and sleep disturbance but did not alter sleep-wake state discrepancy in individuals with insomnia more than sleep hygiene and education. The role of sleep wearable devices among individuals with insomnia requires further research. CLINICAL
trial registrationThe Novel Insomnia Treatment Experiment (NITE): the effectiveness of incorporating appropriate guidance for sleep wearables in users with insomnia. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378452, Australia New Zealand Clinical Trials Registry: ACTRN12619001636145.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.