Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea

Dayzz Live Well

Status: Completed

Conditions: Insomnia; Sleep Apnea

Treatments: Other: Treatment as usual; Behavioral: Dayzz mobile sleep training

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03955120

Dayzz_002

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 4 patient groups

Sleep Apnea- Dayzz

Experimental group

Description:

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

Treatment:

Behavioral: Dayzz mobile sleep training

Sleep Apnea- Treatment as Usual

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as usual

Insomnia - Dayzz

Experimental group

Description:

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.

Treatment:

Behavioral: Dayzz mobile sleep training

Insomnia - Treatment as Usual

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as usual