| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Insomnia Sleep Apnea | Behavioral: Dayzz mobile sleep training Other: Treatment as usual | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea |
| Actual Study Start Date : | January 29, 2019 |
| Estimated Primary Completion Date : | December 30, 2020 |
| Estimated Study Completion Date : | December 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Sleep Apnea- Dayzz
The intervention group is also provided access to the dayzz app, a personalized digital sleep training program. The sleep training begins a sleep assessment questionnaire and ongoing sleep and activity data collection which is used to tailor an individualized sleep training program including behavioral and cognitive techniques to improve the adherence to CPAP. The dayzz sleep program is composed of three main components, (1) a mobile digital program via the dayzz app, (2) guidance of a sleep trainer, and (3) an ambulatory sleep monitoring device. The intervention group meets a CPAP technician at the sleep clinic, as detailed below in the Sleep Apnea TAU group
|
Behavioral: Dayzz mobile sleep training
|
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Active Comparator: Sleep Apnea- Treatment as Usual
The "treatment as usual" [TAU] group meets a CPAP technician at the sleep clinic, who provides the participant with a CPAP device and fits the mask. The will also receive a follow-up visit with the same technician for technical support, mask changes or alterations if needed after an initial 7 to 14-day at home CPAP trial.
|
Other: Treatment as usual
Standard medical care for specific sleep condition
|
|
Experimental: Insomnia - Dayzz
The intervention group is provided access to the dayzz app, a personalized digital sleep training program. The sleep training begins a sleep assessment questionnaire and ongoing sleep and activity data collection which is used to tailor an individualized sleep training program including behavioral and cognitive techniques to improve the insomnia concerns, sleep symptoms, and achieve sleep goals. The dayzz sleep program is composed of three main components, (1) a mobile digital program via the dayzz app, (2) guidance of a sleep trainer, and (3) an ambulatory sleep monitoring device.
|
Behavioral: Dayzz mobile sleep training
|
|
Active Comparator: Insomnia - Treatment as Usual
The "treatment as usual" [TAU] group, will receive standard treatment recommendations for their insomnia, including sleep hygiene suggestions, referral for supportive/non-medical treatments [e.g. relaxation therapies], and if needed hypnotics or other medications prescribed by the sleep clinic physician.
|
Other: Treatment as usual
Standard medical care for specific sleep condition
|
| Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Israel | |
| Carmel Hospital | |
| Haifa, Israel | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | February 7, 2019 | ||||
| First Posted Date ICMJE | May 17, 2019 | ||||
| Last Update Posted Date | July 22, 2020 | ||||
| Actual Study Start Date ICMJE | January 29, 2019 | ||||
| Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea | ||||
| Official Title ICMJE | Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea | ||||
| Brief Summary | The prevalence of sleep disorders has achieved epidemic proportions in Western countries. Despite this, assessment and treatment of sleep disorders remains infrequent, unattainable, and often costly. Dayzz is aware of the need for easily accessible, user-friendly, and affordable treatment strategies for known sleep conditions. This research proposes a randomized controlled outcome study aimed to validate a, digitized, cost-effective mobile app which assesses and manages insomnia and CPAP adherence in persons with sleep apnea. The app's sleep training protocols recommend life-style and behavioral changes and tracks these changes with the aim of improving sleep and well-being. In this study, the dayzz app digital treatment protocol will be compared to the standard treatment for these sleep conditions by a sleep professional. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE |
120 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 30, 2020 | ||||
| Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 21 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Israel | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03955120 | ||||
| Other Study ID Numbers ICMJE | Dayzz_002 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Dayzz Live Well Ltd. | ||||
| Study Sponsor ICMJE | Dayzz Live Well Ltd. | ||||
| Collaborators ICMJE | Israel Innovation Authority | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Dayzz Live Well Ltd. | ||||
| Verification Date | July 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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