InsomniaNCT03955120
Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea
A study testing Dayzz mobile sleep training and Treatment as usual in people with Insomnia and Sleep Apnea, run by Dayzz Live Well Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Insomnia, Sleep Apnea
- What is being tested?
- Dayzz mobile sleep training and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Jan 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Dayzz mobile sleep training, Treatment as usual
- Keywords
- sleep disorders, cognitive and behavioral treatment, digital treatment, insomnia, sleep apnea, sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Apnea Syndromes, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dayzz mobile sleep trainingBehavioural
- 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.
Treatment as usualOther
Standard medical care for specific sleep condition
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time (minutes)
sleep duration in minutes per night (based on nightly sleep diary)
Measured: 3 months to 1 year
Sleep onset latency (minutes)
Number of minutes to fall asleep per night (based on nightly sleep diary)
Measured: 3 months to 1 year
Wake after sleep onset (minutes)
Number of minutes awake in total per night (based on nightly sleep diary)
Measured: 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)
Measured: 3 months to 1 year
Sleep quality
Likert scale of sleep quality between 1 and 10 (based on sleep diary report)
Measured: 3 months to 1 year
Nightly CPAP use
Minutes of wearing the CPAP mask per night (based on sleep diary report)
Measured: 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'.
Measured: 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.
Measured: 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).
Measured: 3 months to 1 year
Secondary outcomes (4)
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.
Measured: 3 months to 1 year
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.
Measured: 3 months to 1 year
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.
Measured: 3 months to 1 year
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.
Measured: 3 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start29 Jan 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dayzz Live Well Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Israel Innovation Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955120
- Sponsor's protocol ID
- Dayzz_002
- Status last verified
- Aug 2021
- First submitted
- 7 Feb 2019
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Dayzz Digital Sleep Training App in Insomnia and Sleep Apnea
- ClinicalTrials.gov ID
- NCT03955120
- Acronym / sponsor ID
- Dayzz_002
- Conditions
- Insomnia, Sleep Apnea
- Keywords
- sleep disorders, cognitive and behavioral treatment, digital treatment, insomnia, sleep apnea, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Dayzz Live Well Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Israel Innovation Authority
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sleep Apnea- Dayzz | Experimental | Behavioral: Dayzz mobile sleep trainingThe 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 | Active comparator | Other: Treatment as usualThe "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. |
| Insomnia - Dayzz | Experimental | Behavioral: Dayzz mobile sleep trainingThe 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 | Active comparator | Other: Treatment as usualThe "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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dayzz mobile sleep training1. 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. | Behavioural | Insomnia - Dayzz, Sleep Apnea- Dayzz |
| Treatment as usualStandard medical care for specific sleep condition | Other | Insomnia - Treatment as Usual, Sleep Apnea- Treatment as Usual |
Primary outcome
Total sleep time (minutes)
Time frame: 3 months to 1 year
sleep duration in minutes per night (based on nightly sleep diary)
Sleep onset latency (minutes)
Time frame: 3 months to 1 year
Number of minutes to fall asleep per night (based on nightly sleep diary)
Wake after sleep onset (minutes)
Time frame: 3 months to 1 year
Number of minutes awake in total per night (based on nightly sleep diary)
Sleep efficiency (percent)
Time frame: 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
Time frame: 3 months to 1 year
Likert scale of sleep quality between 1 and 10 (based on sleep diary report)
Nightly CPAP use
Time frame: 3 months to 1 year
Minutes of wearing the CPAP mask per night (based on sleep diary report)
Excessive daytime sleepiness
Time frame: 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
Time frame: 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.
Insomnia severity
Time frame: 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).
4 secondary outcomes
Work productivity
Time frame: 3 months to 1 year
Insomnia-related quality of life
Time frame: 3 months to 1 year
Sleep Apnea-related Quality of Life-Short form (SAQLI-SF)
Time frame: 3 months to 1 year
The WHO-5 Well-being Index (WHO-5)
Time frame: 3 months to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dayzz mobile sleep training and Treatment as usual in people with Insomnia and Sleep Apnea, run by Dayzz Live Well Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time (minutes) (time frame: 3 months to 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.