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| Name | Class |
|---|---|
| Media Rez | UNKNOWN |
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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.
This study is a Phase II SBIR to further test efficacy of a voice-activated technology to deliver components of cognitive behavioral therapy for insomnia (CBT-I) to breast cancer survivors (BCS) compared to a web-based control. Participants will be randomly assigned to the voice-activated or web-based treatment arms and will complete a 6-week intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voice-Activated Smart Speaker Program | Experimental | Faster Asleep |
|
| Website | Active Comparator | Faster Asleep Website |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faster Asleep Smart Speaker Program | Behavioral | Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Symptoms | 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-threshold or better scores (≤14) among >80% of the intervention participants | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Six Week Change in Sleep Efficiency | Sleep efficiency is calculated by the total time sleeping over the total time in bed. | 6 weeks |
| Six Week Change in Wake After Sleep Onset | Amount of time awake during the night |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale | 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. | 6 weeks |
| End of Study Self-reported Sleep Quality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannah Arem, PhD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41170811 | Derived | Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. | |
| 39316400 | Derived | Starling CM, Greenberg D, Lewin D, Shaw C, Zhou ES, Lieberman D, Chou J, Arem H. Voice-Activated Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2435011. doi: 10.1001/jamanetworkopen.2024.35011. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Voice-Activated Smart Speaker Program | Faster Asleep Faster Asleep Smart Speaker Program: Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia. |
| FG001 | Website | Faster Asleep Website Faster Asleep Website: Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Voice-Activated Smart Speaker Program | Faster Asleep Faster Asleep Smart Speaker Program: Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insomnia Symptoms | 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-threshold or better scores (≤14) among >80% of the intervention participants | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Voice-Activated Smart Speaker Program | Faster Asleep Faster Asleep Smart Speaker Program: Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hannah Arem, Scientific Director, Implementation Science | MedStar Health Research Institute | 2028932430 | hannah.arem@medstar.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2022 | Aug 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2021 | Aug 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Faster Asleep Website | Behavioral | Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program. |
|
| 6 weeks |
| Six Week Change in Sleep Onset Latency | Time to fall asleep | 6 weeks |
| Six Week Change in Total Sleep Time | Total time asleep | 6 weeks |
5-item Likert scale from Very Poor (5) to Very Good (1). |
| 6 weeks |
| 37869974 | Derived | Lewin D, Starling CM, Zhou ES, Greenberg D, Shaw C, Arem H. A novel voice interactive sleep log: concurrent validity with actigraphy and sleep diaries. J Clin Sleep Med. 2024 Feb 1;20(2):309-312. doi: 10.5664/jcsm.10878. |
| 35729605 | Derived | Starling CM, Greenberg D, Zhou E, Lewin D, Morrow AS, Lieberman D, Shaw C, Arem H. Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol. BMC Med Inform Decis Mak. 2022 Jun 21;22(1):163. doi: 10.1186/s12911-022-01902-w. |
| BG001 | Website | Faster Asleep Website Faster Asleep Website: Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital status | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| TNM Cancer Stage at diagnosis | This is using standardized self-reported cancer stage at diagnosis. For example, stage 0 is in situ, stage 1 is localized, stage 4 is metastatic. | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
| OG001 | Website | Faster Asleep Website Faster Asleep Website: Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program. |
|
|
|
| Secondary | Six Week Change in Sleep Efficiency | Sleep efficiency is calculated by the total time sleeping over the total time in bed. | Intent to treat | Posted | Mean | 95% Confidence Interval | proportion of time asleep/time in bed | 6 weeks |
|
|
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| Secondary | Six Week Change in Wake After Sleep Onset | Amount of time awake during the night | Intent to treat | Posted | Mean | 95% Confidence Interval | minutes | 6 weeks |
|
|
|
| Secondary | Six Week Change in Sleep Onset Latency | Time to fall asleep | Intent to treat | Posted | Mean | 95% Confidence Interval | minutes | 6 weeks |
|
|
|
| Secondary | Six Week Change in Total Sleep Time | Total time asleep | Intent to treat | Posted | Mean | 95% Confidence Interval | hours | 6 weeks |
|
|
|
| Other Pre-specified | System Usability Scale | 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. | intent to treat | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Other Pre-specified | End of Study Self-reported Sleep Quality | 5-item Likert scale from Very Poor (5) to Very Good (1). | Intent to treat | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Website | Faster Asleep Website Faster Asleep Website: Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program. | 0 | 38 | 0 | 38 | 0 | 38 |
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| D001523 |
| Mental Disorders |