N/A
Completed N=76
mHealth for Breast Cancer Survivors With Insomnia
Breast Cancer Survivor · Insomnia
Source: ClinicalTrials.gov NCT05233800 ↗
Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Insomnia Symptoms — -8.4; -2.6 units on a scale — p=<0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Symptoms |
-8.4; -2.6 | <0.05 sig |
| SECONDARY Six Week Change in Sleep Efficiency |
0.09; 0.05 | — |
| SECONDARY Six Week Change in Wake After Sleep Onset |
-18.6; -9.1 | — |
| SECONDARY Six Week Change in Sleep Onset Latency |
-13.79; -5.46 | — |
| SECONDARY Six Week Change in Total Sleep Time |
0.26; 0.27 | — |
Eligibility Criteria
Inclusion Criteria
- Willingness to maintain a consistent dosing pattern if currently taking sleep medications or using cannabis for sleep
- Females; Age 18+
- Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG 0-1
- Completed curative treatment (surgery, radiation, chemotherapy) > 3 months prior to enrollment [ongoing adjuvant therapy permitted]
- Has not undergone other behavioral sleep treatment within the prior 12 months
- Score greater than or equal to 8 on the Insomnia Severity Index
- Able to understand and speak English
Exclusion Criteria
- Diagnosed, untreated obstructive sleep apnea syndrome, narcolepsy, restless leg syndrome, periodic limb movement disorder, delayed sleep phase syndrome, central apnea
- Bi-polar disorder, schizophrenia, initiation of psychological treatment within three months, alcohol or drug abuse in the prior year (Alcohol >2 drinks/day or consuming 5+ drinks in a single day in the prior month). (Moderate ADHD, depression and anxiety will not be exclusion criteria.)
- Shift-work in the prior three months or anticipated during the study time
- Planned regular travel out of time zone (>1 hour) during the study period.
- Currently or planning to become pregnant during the study period
Data sourced from ClinicalTrials.gov (NCT05233800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.