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OpenTrials
Completed

NCT Number: NCT04013321

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 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.

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep and Performance Research Center

Spokane, Washington, 99202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Non-English speaking

Treatment and study plan

SleepScore Max coaching feature

Device

The SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep.

Online CBTi

Behavioral

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.

Primary outcomes

  1. Sleep Duration

    Time frame: 10 weeks

    Quantify sleep duration using SleepScore Max in:

    • Passive control insomniacs vs healthy controls
    • Insomnia groups

  2. Sleep Duration

    Time frame: 10 weeks

    Quantify sleep duration using Actigraphy in:

    • Passive control insomniacs vs healthy controls
    • Insomnia groups

Secondary outcomes

  1. Sleep latency

    Time frame: 10 weeks

    Quantify sleep latency using SleepScore Max in:

    • Passive control insomniacs vs healthy controls
    • Insomnia groups

  2. Sleep latency

    Time frame: 10 weeks

    Quantify sleep latency using actigraphy in:

    • Passive control insomniacs vs healthy controls
    • Insomnia groups

  3. Intermittent wakefulness

    Time frame: 10 weeks

    Quantify intermittent wakefulness using SleepScore Max in:

    • Passive control insomniacs vs healthy controls
    • Insomnia groups

  4. Intermittent wakefulness

    Time frame: 10 weeks

    Quantify intermittent wakefulness using actigraphy in:

    • Passive control insomniacs vs healthy controls
    • Insomnia groups

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2019
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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