Back to resultsValidation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea
Primary Purpose
Insomnia, Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dayzz mobile sleep training
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring sleep disorders, cognitive and behavioral treatment, digital treatment, insomnia, sleep apnea, sleep
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
Sites / Locations
- Carmel Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Sleep Apnea- Dayzz
Sleep Apnea- Treatment as Usual
Insomnia - Dayzz
Insomnia - Treatment as Usual
Arm 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
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.
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.
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.
Outcomes
Primary Outcome Measures
Total sleep time (minutes)
sleep duration in minutes per night (based on nightly sleep diary)
Sleep onset latency (minutes)
Number of minutes to fall asleep per night (based on nightly sleep diary)
Wake after sleep onset (minutes)
Number of minutes awake in total per night (based on nightly sleep diary)
Sleep efficiency (percent)
(Number of minutes asleep per night/number of minutes in bed per night)*100 (based on sleep diary data)
Sleep quality
Likert scale of sleep quality between 1 and 10 (based on sleep diary report)
Nightly CPAP use
Minutes of wearing the CPAP mask per night (based on sleep diary report)
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'.
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.
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).
Secondary Outcome Measures
Work productivity
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
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)
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)
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.
Full Information
NCT ID
NCT03955120
First Posted
February 7, 2019
Last Updated
August 18, 2021
Sponsor
Dayzz Live Well Ltd.
Collaborators
Israel Innovation Authority
1. Study Identification
Unique Protocol Identification Number
NCT03955120
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dayzz Live Well Ltd.
Collaborators
Israel Innovation Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Apnea
Keywords
sleep disorders, cognitive and behavioral treatment, digital treatment, insomnia, sleep apnea, sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep Apnea- Dayzz
Arm Type
Experimental
Arm 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
Arm Title
Sleep Apnea- Treatment as Usual
Arm Type
Active Comparator
Arm 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.
Arm Title
Insomnia - Dayzz
Arm Type
Experimental
Arm 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.
Arm Title
Insomnia - Treatment as Usual
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Dayzz mobile sleep training
Intervention Description
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.
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.
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Standard medical care for specific sleep condition
Primary Outcome Measure Information:
Title
Total sleep time (minutes)
Description
sleep duration in minutes per night (based on nightly sleep diary)
Time Frame
3 months to 1 year
Title
Sleep onset latency (minutes)
Description
Number of minutes to fall asleep per night (based on nightly sleep diary)
Time Frame
3 months to 1 year
Title
Wake after sleep onset (minutes)
Description
Number of minutes awake in total per night (based on nightly sleep diary)
Time Frame
3 months to 1 year
Title
Sleep efficiency (percent)
Description
(Number of minutes asleep per night/number of minutes in bed per night)*100 (based on sleep diary data)
Time Frame
3 months to 1 year
Title
Sleep quality
Description
Likert scale of sleep quality between 1 and 10 (based on sleep diary report)
Time Frame
3 months to 1 year
Title
Nightly CPAP use
Description
Minutes of wearing the CPAP mask per night (based on sleep diary report)
Time Frame
3 months to 1 year
Title
Excessive daytime sleepiness
Description
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'.
Time Frame
3 months to 1 year
Title
Sleep symptom screening questionnaire
Description
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.
Time Frame
3 months to 1 year
Title
Insomnia severity
Description
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).
Time Frame
3 months to 1 year
Secondary Outcome Measure Information:
Title
Work productivity
Description
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.
Time Frame
3 months to 1 year
Title
Insomnia-related quality of life
Description
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.
Time Frame
3 months to 1 year
Title
Sleep Apnea-related Quality of Life-Short form (SAQLI-SF)
Description
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.
Time Frame
3 months to 1 year
Title
The WHO-5 Well-being Index (WHO-5)
Description
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.
Time Frame
3 months to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Carmel Hospital
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea
We'll reach out to this number within 24 hrs