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出境医 / 临床实验 / Naturalistic Monitoring and Treatment of Chronic Insomnia

Naturalistic Monitoring and Treatment of Chronic Insomnia

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Device: SleepScore Max coaching feature Behavioral: Online CBTi Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Naturalistic Monitoring and Treatment of Chronic Insomnia
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Test intervention group
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.
 Device: SleepScore Max coaching feature
The SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep.
Active Comparator: Active control
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).
 Behavioral: Online CBTi
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.
No Intervention: Passive control
Chronic insomniacs in the passive control group will track their sleep using the SleepScore Max device, but without the feedback or coaching feature.
No Intervention: Healthy control
Healthy sleepers will track their sleep using the SleepScore Max device, but without the feedback or coaching feature.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Devon A Hansen, PhD 509-358-7754 devon.hansen@wsu.edu

Sponsors and Collaborators
Washington State University
National Institutes of Health (NIH)
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Sleep latency [ Time Frame: 10 weeks ]
    Quantify sleep latency using SleepScore Max in:
    • Passive control insomniacs vs healthy controls
    • Insomnia groups
  • Sleep latency [ Time Frame: 10 weeks ]
    Quantify sleep latency using actigraphy in:
    • Passive control insomniacs vs healthy controls
    • Insomnia groups
  • Intermittent wakefulness [ Time Frame: 10 weeks ]
    Quantify intermittent wakefulness using SleepScore Max in:
    • Passive control insomniacs vs healthy controls
    • Insomnia groups
  • Intermittent wakefulness [ Time Frame: 10 weeks ]
    Quantify intermittent wakefulness using actigraphy in:
    • Passive control insomniacs vs healthy controls
    • Insomnia groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naturalistic Monitoring and Treatment of Chronic Insomnia
Official Title  ICMJE Naturalistic Monitoring and Treatment of Chronic Insomnia
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Insomnia
Intervention  ICMJE
  • Device: SleepScore Max coaching feature
    The SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep.
  • Behavioral: Online CBTi
    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 Arms  ICMJE
  • Experimental: Test intervention group
    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.
    Intervention: Device: SleepScore Max coaching feature
  • Active Comparator: Active control
    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).
    Intervention: Behavioral: Online CBTi
  • No Intervention: Passive control
    Chronic insomniacs in the passive control group will track their sleep using the SleepScore Max device, but without the feedback or coaching feature.
  • No Intervention: Healthy control
    Healthy sleepers will track their sleep using the SleepScore Max device, but without the feedback or coaching feature.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Devon A Hansen, PhD 509-358-7754 devon.hansen@wsu.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013321
Other Study ID Numbers  ICMJE 17379-002
KL2TR002317 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: pending
Responsible Party Washington State University
Study Sponsor  ICMJE Washington State University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account Washington State University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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