Naturalistic Monitoring and Treatment of Chronic Insomnia

Chronic Insomnia Clinical Trial

Official title:

Naturalistic Monitoring and Treatment of Chronic Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013321
• Other study ID #: 17379-002
• Secondary ID: KL2TR002317
• Status: Completed
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: October 10, 2021

Study information

• Verified date: April 2023
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Sleep and Performance Research Center	Spokane	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Washington State University	National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Duration	Quantify sleep duration using SleepScore Max in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks
Primary	Sleep Duration	Quantify sleep duration using Actigraphy in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks
Secondary	Sleep latency	Quantify sleep latency using SleepScore Max in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks
Secondary	Sleep latency	Quantify sleep latency using actigraphy in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks
Secondary	Intermittent wakefulness	Quantify intermittent wakefulness using SleepScore Max in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks
Secondary	Intermittent wakefulness	Quantify intermittent wakefulness using actigraphy in: Passive control insomniacs vs healthy controls; Insomnia groups	10 weeks