NCT04013321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 23, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2021

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

June 17, 2019

Last Update Submit

April 24, 2023

Conditions

Chronic Insomnia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Sleep latency

    10 weeks

  • Sleep latency

    10 weeks

  • Intermittent wakefulness

    10 weeks

  • Intermittent wakefulness

    10 weeks

Study Arms (4)

Test intervention group

EXPERIMENTAL

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

Active control

ACTIVE COMPARATOR

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

Passive control

NO INTERVENTION

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

Healthy control

NO INTERVENTION

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

Interventions

SleepScore Max coaching featureDEVICE

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

Test intervention group
Online CBTiBEHAVIORAL

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.

Active control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep and Performance Research Center

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 17, 2019

First Posted

July 9, 2019

Study Start

January 23, 2020

Primary Completion

August 10, 2021

Study Completion

October 10, 2021

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

pending

Locations

US(1)