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

NCT03955120 | Completed

• 1 other identifier: Dayzz_002
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Sleep Apnea

Keywords

sleep disorders; cognitive and behavioral treatment; digital treatment; insomnia; sleep apnea; sleep

Outcome Measures

Primary Outcomes (9)

• Total sleep time (minutes)

  sleep duration in minutes per night (based on nightly sleep diary)

  3 months to 1 year

• Sleep onset latency (minutes)

  Number of minutes to fall asleep per night (based on nightly sleep diary)

  3 months to 1 year

• Wake after sleep onset (minutes)

  Number of minutes awake in total per night (based on nightly sleep diary)

  3 months to 1 year

• Sleep efficiency (percent)

  (Number of minutes asleep per night/number of minutes in bed per night)\*100 (based on sleep diary data)

  3 months to 1 year

• Sleep quality

  Likert scale of sleep quality between 1 and 10 (based on sleep diary report)

  3 months to 1 year

• Nightly CPAP use

  Minutes of wearing the CPAP mask per night (based on sleep diary report)

  3 months to 1 year

• Excessive daytime sleepiness

  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'.

  3 months to 1 year

• Sleep symptom screening questionnaire

  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.

  3 months to 1 year

• Insomnia severity

  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).

  3 months to 1 year

Secondary Outcomes (4)

• Work productivity

  3 months to 1 year

• Insomnia-related quality of life

  3 months to 1 year

• Sleep Apnea-related Quality of Life-Short form (SAQLI-SF)

  3 months to 1 year

• The WHO-5 Well-being Index (WHO-5)

  3 months to 1 year

Study Arms (4)

Sleep Apnea- Dayzz

EXPERIMENTAL

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

Sleep Apnea- Treatment as Usual

ACTIVE COMPARATOR

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

Insomnia - Dayzz

EXPERIMENTAL

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

Insomnia - Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Dayzz mobile sleep training BEHAVIORAL

1. The dayzz digital sleep program provides each user with relevant educational materials (depending on their sleep condition), sleep tracking, and sleep or health-related tasks or challenges pertaining to their sleep or sleep difficulties. 2. Each app user is matched with a "sleep trainer" who will communicate with them via a "chat" option within the dayzz app and who will support the participants with any sleep training issues or technical aspects of all app for the duration of the treatment program. 3. Participants receive a wrist-worn device for monitoring sleep and activity patterns, a Fitbit fitness tracker (www.fitbit.com), to be worn for the duration of the study.

Insomnia - Dayzz; Sleep Apnea- Dayzz

Treatment as usual OTHER

Standard medical care for specific sleep condition

Insomnia - Treatment as Usual; Sleep Apnea- Treatment as Usual

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dayzz Live Well Ltd.: lead
• Israel Innovation Authority: collaborator

Study Sites (1)

Carmel Hospital

Haifa, Israel

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Apnea Syndromes; Sleep Wake Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: May 17, 2019
• Study Start: January 29, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

IL (1)