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

Not Applicable

Completed

• Conditions: Insomnia; Sleep Apnea
• Interventions: Behavioral: Dayzz mobile sleep training; Other: Treatment as usual

• Registration Number: NCT03955120
• Lead Sponsor: Dayzz Live Well Ltd.

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 available

Study Timeline

• Study Start: 2019-01-29
• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insomnia - Dayzz	Dayzz mobile sleep training	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.
Insomnia - Treatment as Usual	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.
Sleep Apnea- Dayzz	Dayzz mobile sleep training	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
Sleep Apnea- Treatment as Usual	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.

Primary Outcome Measures

Name	Time	Method
Sleep onset latency (minutes)	3 months to 1 year	Number of minutes to fall asleep per night (based on nightly sleep diary)
Sleep efficiency (percent)	3 months to 1 year	(Number of minutes asleep per night/number of minutes in bed per night)\*100 (based on sleep diary data)
Sleep quality	3 months to 1 year	Likert scale of sleep quality between 1 and 10 (based on sleep diary report)
Nightly CPAP use	3 months to 1 year	Minutes of wearing the CPAP mask per night (based on sleep diary report)
Insomnia severity	3 months to 1 year	The Insomnia Severity Index (ISI) is a well-validated 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia over the past month (Morin, 1993). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Total sleep time (minutes)	3 months to 1 year	sleep duration in minutes per night (based on nightly sleep diary)
Wake after sleep onset (minutes)	3 months to 1 year	Number of minutes awake in total per night (based on nightly sleep diary)
Excessive daytime sleepiness	3 months to 1 year	The Epworth Sleepiness Scale (ESS): The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity or their 'daytime sleepiness'.
Sleep symptom screening questionnaire	3 months to 1 year	The Dayzz Sleep Questionnaire is a digitized screening measure that assesses sleep quantity and quality and presence/risk for specific sleep disorders. It is composed of some self-rated items, assessing sleep amounts, sleep quality, excessive sleepiness, and risk factors for sleep-related breathing disorders, symptoms of insomnia and sleep/wake circadian rhythms. The questions are based on the International Classification of Sleep Disorders (3rd Edition; American Academy of Sleep Medicine) diagnostic criteria for four common categories of sleep disorders: Insomnia, Insufficient Sleep Syndrome, Sleep Apnea Disorders, and Circadian Rhythm Sleep-Wake Disorders.

Secondary Outcome Measures

Name	Time	Method
Work productivity	3 months to 1 year	The Work Productivity and Activity Impairment Questionnaire-Specific Health problem (WPAI:SHP): The WPAI is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to a specific health problem (Reilly et al, 1993). WPAI:SHP outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.
Insomnia-related quality of life	3 months to 1 year	The Glasgow Sleep Impact Index (GSII). Administered only to the insomnia sample. The GSII is a self-report measure which asks patients to generate, and assess, three domains of measure insomnia-related quality of life impairment. These three patient-generated areas of impairment are ranked in order of concern (1-3; i.e. 1=the most concerning impairment), and then rated on a visual analogue scale with respect to impact in the past two weeks. Patients re-rate these specified areas of impairment, post-intervention, permitting both individual and group-level analyses.
Sleep Apnea-related Quality of Life-Short form (SAQLI-SF)	3 months to 1 year	The SAQLI- SF (for sleep apnea sample only) measures the effects of sleep apnea on a person's quality of life. The questions represent four quality of life domains: Daily Activities, Social Interactions, Emotions,and Symptoms. Two total scores will be generated, which reflect the pre- and post-treatment quality of life. The total scores range between 1-14, with higher values representing poorer outcomes. No subscale scores are generated.
The WHO-5 Well-being Index (WHO-5)	3 months to 1 year	The WHO-5 Well-being Index (WHO-5) is a short, self-administered questionnaire measuring psychological well-being. It covers 5 positively worded items, related to positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interests (being interested in things). Each of the five items is rated on a 6-point Likert scale from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25. Then the scores are transformed to 0-100 by multiplying by 4 which provides the total score, with higher scores meaning better well-being. The scale does not generate subscale scores.

Trial Locations

Locations (1)

Carmel Hospital; 🇮🇱 Haifa, Israel