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Naturalistic Monitoring and Treatment of Chronic Insomnia
NCT04013321 · View on ClinicalTrials.gov ↗
Study 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. 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.
Conditions Studied
Interventions
- DEVICE SleepScore Max coaching feature
- BEHAVIORAL Online CBTi
Study Locations (1)
Washington
- Sleep and Performance Research Center — Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2020-01-23 |
| Est. Completion | 2021-10-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04013321
The ClinicalTrials.gov registry entry for NCT04013321 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington State University, which has 84 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Insomnia appearing as the primary indexed condition, and to 2 interventions — of which SleepScore Max coaching feature is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04013321 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04013321 about?
NCT04013321 is a clinical study titled "Naturalistic Monitoring and Treatment of Chronic Insomnia". 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 ac...
What is the current status of trial NCT04013321?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2020-01-23. Estimated completion is 2021-10-10.
What conditions does trial NCT04013321 study?
This clinical trial studies the following conditions: Chronic Insomnia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04013321?
The interventions under investigation include: SleepScore Max coaching feature (DEVICE), Online CBTi (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04013321?
This trial is sponsored by Washington State University, which has 84 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04013321 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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