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.

Study Overview

• Status: Completed
• Conditions: Chronic Insomnia
• Intervention / Treatment: Device: SleepScore Max coaching feature; Behavioral: Online CBTi

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: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devon A Hansen, PhD; Phone Number: 509-358-7754; Email: devon.hansen@wsu.edu

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99202
      • Sleep and Performance Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Duration	Quantify sleep duration using SleepScore Max in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks
Sleep Duration	Quantify sleep duration using Actigraphy in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep latency	Quantify sleep latency using SleepScore Max in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks
Sleep latency	Quantify sleep latency using actigraphy in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks
Intermittent wakefulness	Quantify intermittent wakefulness using SleepScore Max in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks
Intermittent wakefulness	Quantify intermittent wakefulness using actigraphy in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks

Collaborators and Investigators

• Sponsor: Washington State University
• Collaborators: National Institutes of Health (NIH); National Center for Advancing Translational Sciences (NCATS)

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): October 10, 2021

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 17379-002; KL2TR002317 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: pending

Drug and device information, study documents

• 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