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Naturalistic Monitoring and Treatment of Chronic Insomnia

Primary Purpose

Chronic Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SleepScore Max coaching feature
Online CBTi
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sleep and Performance Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

No Intervention

Arm Label

Test intervention group

Active control

Passive control

Healthy control

Arm Description

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.

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).

Chronic insomniacs in the passive control group will track their sleep using the SleepScore Max device, but without the feedback or coaching feature.

Healthy sleepers will track their sleep using the SleepScore Max device, but without the feedback or coaching feature.

Outcomes

Primary Outcome Measures

Sleep Duration
Quantify sleep duration using SleepScore Max in: Passive control insomniacs vs healthy controls Insomnia groups
Sleep Duration
Quantify sleep duration using Actigraphy in: Passive control insomniacs vs healthy controls Insomnia groups

Secondary Outcome Measures

Sleep latency
Quantify sleep latency using SleepScore Max in: Passive control insomniacs vs healthy controls Insomnia groups
Sleep latency
Quantify sleep latency using actigraphy in: Passive control insomniacs vs healthy controls Insomnia groups
Intermittent wakefulness
Quantify intermittent wakefulness using SleepScore Max in: Passive control insomniacs vs healthy controls Insomnia groups
Intermittent wakefulness
Quantify intermittent wakefulness using actigraphy in: Passive control insomniacs vs healthy controls Insomnia groups

Full Information

First Posted
June 17, 2019
Last Updated
April 24, 2023
Sponsor
Washington State University
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT04013321
Brief Title
Naturalistic Monitoring and Treatment of Chronic Insomnia
Official Title
Naturalistic Monitoring and Treatment of Chronic Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Passive control
Arm Type
No Intervention
Arm Description
Chronic insomniacs in the passive control group will track their sleep using the SleepScore Max device, but without the feedback or coaching feature.
Arm Title
Healthy control
Arm Type
No Intervention
Arm Description
Healthy sleepers will track their sleep using the SleepScore Max device, but without the feedback or coaching feature.
Intervention Type
Device
Intervention Name(s)
SleepScore Max coaching feature
Intervention Description
The SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep.
Intervention Type
Behavioral
Intervention Name(s)
Online CBTi
Intervention Description
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 Outcome Measure Information:
Title
Sleep Duration
Description
Quantify sleep duration using SleepScore Max in: Passive control insomniacs vs healthy controls Insomnia groups
Time Frame
10 weeks
Title
Sleep Duration
Description
Quantify sleep duration using Actigraphy in: Passive control insomniacs vs healthy controls Insomnia groups
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Sleep latency
Description
Quantify sleep latency using SleepScore Max in: Passive control insomniacs vs healthy controls Insomnia groups
Time Frame
10 weeks
Title
Sleep latency
Description
Quantify sleep latency using actigraphy in: Passive control insomniacs vs healthy controls Insomnia groups
Time Frame
10 weeks
Title
Intermittent wakefulness
Description
Quantify intermittent wakefulness using SleepScore Max in: Passive control insomniacs vs healthy controls Insomnia groups
Time Frame
10 weeks
Title
Intermittent wakefulness
Description
Quantify intermittent wakefulness using actigraphy in: Passive control insomniacs vs healthy controls Insomnia groups
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Sleep and Performance Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
pending

Learn more about this trial

Naturalistic Monitoring and Treatment of Chronic Insomnia

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