Clinical trial NCT03955120: Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea
Official title: Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep Apnea
Keywords: sleep disorders
cognitive and behavioral treatment
digital treatment
insomnia
sleep apnea
sleep
Lead sponsor: Dayzz Live Well Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Israel Innovation Authority
First posted: 2019-05-17
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients aged 21-65 years of age referred to the Carmel Hospital sleep clinic and diagnosed by the clinic physician with either Sleep Apnea (referred for CPAP treatment) or Insomnia.

Exclusion Criteria:

* Patient age \<21 years.
* Patient who is not a member of Clalit Healthcare services.
* Persons with insufficient control of the English language required for adequate use of app.
* Persons with insufficient experience/knowledge and/or use of digital apps/smartphones.
* Persons with serious medical or psychiatric conditions.
* Women who are pregnant or breastfeeding.
* Nighttime shift-workers.
* Persons who are unable to provide consent due to mental incapacity.
* Persons referred for evaluation of sleep by Ministry of Transportation (for licensing purposes).
* Persons with comorbid insomnia and sleep apnea

Primary outcomes:
measure: Total sleep time (minutes)
timeFrame: 3 months to 1 year
measure: Sleep onset latency (minutes)
timeFrame: 3 months to 1 year
measure: Wake after sleep onset (minutes)
timeFrame: 3 months to 1 year
measure: Sleep efficiency (percent)
timeFrame: 3 months to 1 year
measure: Sleep quality
timeFrame: 3 months to 1 year
measure: Nightly CPAP use
timeFrame: 3 months to 1 year
measure: Excessive daytime sleepiness
timeFrame: 3 months to 1 year
measure: Sleep symptom screening questionnaire
timeFrame: 3 months to 1 year
measure: Insomnia severity
timeFrame: 3 months to 1 year
Secondary outcomes:
measure: Work productivity
timeFrame: 3 months to 1 year
measure: Insomnia-related quality of life
timeFrame: 3 months to 1 year
measure: Sleep Apnea-related Quality of Life-Short form (SAQLI-SF)
timeFrame: 3 months to 1 year
measure: The WHO-5 Well-being Index (WHO-5)
timeFrame: 3 months to 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Hospital
Study officials:
References: