18 and older, female only, with Breast Cancer Survivor or Insomnia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Insomnia SymptomsPrimary· 6 weeks
Data will be collected on the Insomnia Severity Index (ISI) total score pre- and post-intervention as our primary outcome. The ISI is a seven-item questionnaire with response categories from 0-4 (total score 0-28) asking about sleep patterns and specifically characterizing insomnia over the two weeks prior. The ISI defines 'no clinically significant' insomnia as a score of 0-7, 'sub-threshold' insomnia as a score of 8-14, 'moderate severity clinical' insomnia' a scores of 15-21, and 'severe clinical' insomnia as a score of 22-28. Clinically relevant target for success is to achieve sub-thresho
Group
Value
95% CI
Voice-Activated Smart Speaker Program
-8.4
± 4.7
Website
-2.6
± 3.5
Six Week Change in Sleep EfficiencySecondary· 6 weeks
Sleep efficiency is calculated by the total time sleeping over the total time in bed.
Group
Value
95% CI
Voice-Activated Smart Speaker Program
0.09
0.07 – 0.11
Website
0.05
0.03 – 0.07
Six Week Change in Wake After Sleep OnsetSecondary· 6 weeks
Amount of time awake during the night
Group
Value
95% CI
Voice-Activated Smart Speaker Program
-18.6
-23.9 – -13.36
Website
-9.1
-14.6 – -3.63
Six Week Change in Sleep Onset LatencySecondary· 6 weeks
Time to fall asleep
Group
Value
95% CI
Voice-Activated Smart Speaker Program
-13.79
-18.2 – -9.33
Website
-5.46
-10.1 – -0.86
Six Week Change in Total Sleep TimeSecondary· 6 weeks
Total time asleep
Group
Value
95% CI
Voice-Activated Smart Speaker Program
0.26
0.06 – 0.45
Website
0.27
0.06 – 0.47
System Usability ScaleSecondary· 6 weeks
A 10-item scale on general usability of technology. This provides a score of 0-100, with above 68 indicating better than average usability, where higher is better. This is a normalized score and not a percentage.
Group
Value
95% CI
Voice-Activated Smart Speaker Program
72.2
± 16.6
Website
50.79
± 15.9
End of Study Self-reported Sleep QualitySecondary· 6 weeks
5-item Likert scale from Very Poor (5) to Very Good (1).
Group
Value
95% CI
Voice-Activated Smart Speaker Program
2.44
± 0.08
Website
3.03
± 0.08
Sponsor's own description
The aim of this study is to determine the impact of the voice-activated smart speaker CBT-I components on insomnia symptoms among breast cancer survivors using a randomized clinical trial.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medstar Health Research Institute
Last refreshed: 24 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05233800.