Chronic InsomniaNCT04013321
Naturalistic Monitoring and Treatment of Chronic Insomnia
A study testing SleepScore Max coaching feature and Online CBTi in people with Chronic Insomnia, run by Washington State University at 1 site in United States.
Trial summary
90 individuals with chronic insomniacs and 30 healthy normal sleepers will have their sleep monitored by the SleepScore Max for 10 weeks. Individuals with chronic insomnia will be randomized into one of three groups (30 subjects in each): a test intervention group, a passive control group, and an active control group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- SleepScore Max coaching feature and Online CBTi
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 10 Oct 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Physically and psychologically healthy (except for chronic insomnia for the insomnia participants) as assessed by questionnaires and history
- No sleep disorders other than chronic insomnia (for insomnia participants only) as assessed by questionnaires and history
- Has daily access to an iPhone
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep and Performance Research Center
Spokane, Washington, 99202
About this study
90 individuals with chronic insomniacs and 30 healthy normal sleepers will have their sleep monitored by the SleepScore Max for 10 weeks. Individuals with chronic insomnia will be randomized into one of three groups (30 subjects in each): a test intervention group, a passive control group, and an active control group. The purpose of the study is to examine if the SleepScore max provides a accurate measurement of sleep relative to a validated, wrist-worn sleep monitor and if a integrated coaching feature within the SleepScore Max facilitates improvement in sleep relative to other gold standard treatment methods.
Read the detailed description
90 chronic insomniacs, carefully screened using the criteria of Chronic Insomnia Disorder according to the International Classification of Sleep Disorders 3 (ICSD-3), will be studied. Additionally, 30 healthy normal sleepers will be included as controls. The duration of study participation will be 10 weeks. All subjects will wear an actigraph during week 1 to record baseline sleep patterns, followed by 8 weeks of recording with the SleepScore Max. During week 10, the subjects will wear the actigraph again to measure post intervention sleep. The healthy subjects will be used as a control to test if the SleepScore Max can track sleep well as compared to actigraphy. The subjects with chronic insomnia will be randomized into one of three groups (30 subjects in each). One of these groups is the test intervention group, in which subjects will track their sleep with the SleepScore Max device and will receive feedback and coaching from the Smartphone app associated with the device. The other two groups will serve as passive and active controls. The passive control group will track their sleep using the SleepScore Max device, but without any feedback or coaching. The active control group will also be tracking their sleep with the device, without feedback or coaching, but they will also undergo online CBTi which is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep.
- Conditions
- Chronic Insomnia
- Being tested
- SleepScore Max coaching feature, Online CBTi
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepScore Max coaching featureDevice
The SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep.
Online CBTiBehavioural
Online Cognitive Behavioral Therapy for insomnia is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep.
| Study group | Role | What they receive |
|---|---|---|
| Test intervention group | Experimental | Chronic insomniacs will track their sleep with the SleepScore Max device and will receive feedback and coaching from the Smartphone app associated with the device. Receives: Device: SleepScore Max coaching feature |
| Active control | Active comparator | Chronic insomniacs in the active control group will be tracking their sleep with the device, without feedback or coaching. But they will also undergo online cognitive behavioral therapy for insomnia (CBTi). Receives: Behavioral: Online CBTi |
| Passive control | No intervention | Chronic insomniacs in the passive control group will track their sleep using the SleepScore Max device, but without the feedback or coaching feature. |
| Healthy control | No intervention | Healthy sleepers will track their sleep using the SleepScore Max device, but without the feedback or coaching feature. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Duration
Quantify sleep duration using SleepScore Max in:
- Passive control insomniacs vs healthy controls
- Insomnia groups
Measured: 10 weeks
Sleep Duration
Quantify sleep duration using Actigraphy in:
- Passive control insomniacs vs healthy controls
- Insomnia groups
Measured: 10 weeks
Secondary outcomes (4)
Sleep latency
Quantify sleep latency using SleepScore Max in:
- Passive control insomniacs vs healthy controls
- Insomnia groups
Measured: 10 weeks
Sleep latency
Quantify sleep latency using actigraphy in:
- Passive control insomniacs vs healthy controls
- Insomnia groups
Measured: 10 weeks
Intermittent wakefulness
Quantify intermittent wakefulness using SleepScore Max in:
- Passive control insomniacs vs healthy controls
- Insomnia groups
Measured: 10 weeks
Intermittent wakefulness
Quantify intermittent wakefulness using actigraphy in:
- Passive control insomniacs vs healthy controls
- Insomnia groups
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start23 Jan 2020
- Primary completion10 Aug 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Devon Hansen, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013321
- Sponsor's protocol ID
- 17379-002
- Other IDs
- KL2TR002317
- Status last verified
- Apr 2023
- First submitted
- 17 Jun 2019
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: pending
Publications
Hansen DA, Peterson ME, Finlay MG, Gottlieb E, Danoff-Burg S, Raymann RJ, Buchwald D, Watson NF. Assessing Night-to-Night Sleep Variability as a Hallmark of Chronic Insomnia Using Longitudinal, Contactless, Mobile Sleep Monitoring: Prospective Cohort Study. JMIR Form Res. 2026 Mar 18;10:e73969. doi: 10.2196/73969.
PubMed 41849211
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturalistic Monitoring and Treatment of Chronic Insomnia
- ClinicalTrials.gov ID
- NCT04013321
- Acronym / sponsor ID
- 17379-002
- Conditions
- Chronic Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 9 Jul 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.
90 individuals with chronic insomniacs and 30 healthy normal sleepers will have their sleep monitored by the SleepScore Max for 10 weeks. Individuals with chronic insomnia will be randomized into one of three groups (30 subjects in each): a test intervention group, a passive control group, and an active control group. The purpose of the study is to examine if the SleepScore max provides a accurate measurement of sleep relative to a validated, wrist-worn sleep monitor and if a integrated coaching feature within the SleepScore Max facilitates improvement in sleep relative to other gold standard treatment methods.
Detailed description
90 chronic insomniacs, carefully screened using the criteria of Chronic Insomnia Disorder according to the International Classification of Sleep Disorders 3 (ICSD-3), will be studied. Additionally, 30 healthy normal sleepers will be included as controls. The duration of study participation will be 10 weeks. All subjects will wear an actigraph during week 1 to record baseline sleep patterns, followed by 8 weeks of recording with the SleepScore Max. During week 10, the subjects will wear the actigraph again to measure post intervention sleep. The healthy subjects will be used as a control to test if the SleepScore Max can track sleep well as compared to actigraphy. The subjects with chronic insomnia will be randomized into one of three groups (30 subjects in each). One of these groups is the test intervention group, in which subjects will track their sleep with the SleepScore Max device and will receive feedback and coaching from the Smartphone app associated with the device. The other two groups will serve as passive and active controls. The passive control group will track their sleep using the SleepScore Max device, but without any feedback or coaching. The active control group will also be tracking their sleep with the device, without feedback or coaching, but they will also undergo online CBTi which is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test intervention group | Experimental | Device: SleepScore Max coaching featureChronic insomniacs will track their sleep with the SleepScore Max device and will receive feedback and coaching from the Smartphone app associated with the device. |
| Active control | Active comparator | Behavioral: Online CBTiChronic insomniacs in the active control group will be tracking their sleep with the device, without feedback or coaching. But they will also undergo online cognitive behavioral therapy for insomnia (CBTi). |
| Passive control | No intervention | –Chronic insomniacs in the passive control group will track their sleep using the SleepScore Max device, but without the feedback or coaching feature. |
| Healthy control | No intervention | –Healthy sleepers will track their sleep using the SleepScore Max device, but without the feedback or coaching feature. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65
- Physically and psychologically healthy (except for chronic insomnia for the insomnia participants) as assessed by questionnaires and history
- No sleep disorders other than chronic insomnia (for insomnia participants only) as assessed by questionnaires and history
- Has daily access to an iPhone
Key exclusion criteria (1 listed)
- Non-English speaking
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 |
|---|---|---|
| SleepScore Max coaching featureThe SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep. | Device | Test intervention group |
| Online CBTiOnline Cognitive Behavioral Therapy for insomnia is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep. | Behavioural | Active control |
Primary outcome
Sleep Duration
Time frame: 10 weeks
Quantify sleep duration using SleepScore Max in: * Passive control insomniacs vs healthy controls * Insomnia groups
Sleep Duration
Time frame: 10 weeks
Quantify sleep duration using Actigraphy in: * Passive control insomniacs vs healthy controls * Insomnia groups
4 secondary outcomes
Sleep latency
Time frame: 10 weeks
Sleep latency
Time frame: 10 weeks
Intermittent wakefulness
Time frame: 10 weeks
Intermittent wakefulness
Time frame: 10 weeks
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 26 Apr 2023.
- Derived from this study: PubMed 41849211Hansen DA, Peterson ME, Finlay MG, Gottlieb E, Danoff-Burg S, Raymann RJ, Buchwald D, Watson NF. Assessing Night-to-Night Sleep Variability as a Hallmark of Chronic Insomnia Using Longitudinal, Contactless, Mobile Sleep Monitoring: Prospective Cohort Study. JMIR Form Res. 2026 Mar 18;10:e73969. doi: 10.2196/73969.
- Individual participant dataSharing planned: No. pending
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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 SleepScore Max coaching feature and Online CBTi in people with Chronic Insomnia, run by Washington State University at 1 site in United States.
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 4 inclusion and 1 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 26 Apr 2023. 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 United States. 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?
Sleep Duration (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013321, which also lists 1 linked publication.
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 26 Apr 2023.