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DOZE Sleep App for Youth With Sleep Disturbance

Primary Purpose

Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
DOZE Sleep App
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Adolescents, Young Adults

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 15 and 24 years
  • Experiencing sleep disturbance

Exclusion Criteria:

  • None

Sites / Locations

  • Ryerson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DOZE Users

Arm Description

Adolescents and young adults (AYAs) using DOZE for sleep disturbance.

Outcomes

Primary Outcome Measures

Treatment Evaluation Questionnaire
A quantitative questionnaire consisting of 5 questions evaluating treatment credibility. Scores range from 5 to 35, with higher scores indicating a more favourable evaluation of treatment.
Acceptability E-Scale
A quantitative questionnaire, created for the purposes of this study, consisting of 6 questions assessing the acceptability of the app (helpfulness, usefulness, understandability, ease of use, enjoyment, and overall satisfaction) using a 5-point Likert scale. Scores range from 5 to 30, with higher scores indicating greater acceptability of the app.
Qualitative Assessment: Post-Test
A qualitative questionnaire, created for the purposes of this study, consisting of 4 open-ended questions to obtain feedback on the app. Because of its qualitative nature, no scores are associated with this outcome; rather, this assessment will be used to receive open-ended feedback from the participants about the aspects of the app that they did and did not like.

Secondary Outcome Measures

Google Analytics: time spent on each app page
Google Analytics will be used to track the time spent by each participant on each page/area of the app. This information will be used qualitatively to understand which aspects of the app were found least/most helpful.
Google Analytics: number of times app logged in
Google Analytics will be used to track the number of times each participant logged into the app. Greater adherence to app use (and daily sleep tracking) indicates greater acceptability of the app.
Google Analytics: number of times app used
Google Analytics will be used to track the number of times participants used the app. Greater app use indicates greater acceptability of the app. Google Analytics will provide a count of the number of times the app was accessed.
Google Analytics: number of quizzes completed
Google Analytics will be used to track the number of quizzes each participant completed. Quizzes are included in the app under the "Tips" heading, and include questions that related to chronotype, difficulty winding down, difficulty getting up, sleep drunkenness, trouble staying awake, and fatigue. Quizzes are an optional feature of the app which are used to provide participants with psychoeducation about these topics and how they relate to symptoms of sleep disturbance.
Sleep diary parameters
Data extracted from sleep diaries, including variability in bedtime, variability in rise time, total sleep time, total time in bed, sleep onset latency, wake after sleep onset, number of awakenings, naps
Center for Epidemiological Studies Depression Scale-Revised (9 items)
Scores range from 0 to 36, with higher scores indicating more severe depressive symptoms.
State-Trait Inventory of Cognitive and Somatic Anxiety
This measure includes two scales: a state scale (with scores ranging from 21 to 84) and a trait scale (with scores ranging from 21 to 84). Higher scores on both scales indicate more severe symptoms of anxiety.
Fatigue Severity Scale
A total score is computed by summing all of the items (range: 9 to 63) and dividing the score by the number of items to yield an item average. Average scores range from 1 to 7, with higher average scores indicating more impairment due to fatigue.
Cleveland Adolescent Sleepiness Scale
Scores range from 0 to 64, with higher scores indicating greater sleepiness.
Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
Assesses health-related quality of life using 8 subscales: vitality, physical functioning, bodily pain, general, health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. Items in which higher scores indicate better functioning are reverse scored when creating subscale scores. Subscale scores are converted to T scores ranging from 0 to 100, with higher scores indicating worse functioning.

Full Information

First Posted
May 5, 2019
Last Updated
May 21, 2019
Sponsor
Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT03960294
Brief Title
DOZE Sleep App for Youth With Sleep Disturbance
Official Title
Evidence-Based e-Health Solutions for Youth With Mental Illness - Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Insomnia is a highly prevalent problem among adolescents and young adults (AYAs) with mental health issues. Although evidence-based treatments to quickly address insomnia exist, access to such treatments is limited and there is very little research in AYAs. Furthermore, some of the sleep problems of AYA are unique (e.g., voluntary sleep restriction, circadian phase delay, very poor sleep hygiene), so pediatric and adult programs are not suitable for this age group. This study will test an innovative program that consists of an integrated smart phone application (app) and web self-management system ("DOZE") to help adolescents and young adults sleep better. The first phase of this project, now completed, involved interviewing primary stakeholders of the app (AYAs) to evaluate a low-fidelity prototype of the app and to gather information regarding their opinion about what tools participants would use to improve their health and/or sleep. Using the data from phase I, the investigators have created an app that is acceptable, useful and easy to use while meeting the needs of AYAs experiencing sleep problems. In this study, the investigators will conduct an open trial of the app with 145 AYAs to evaluate usability, acceptability, and sleep and corollary outcomes using a mixed methods design. The investigators hypothesize: That participants (AYAs) will find the app satisfactory and credible; DOZE will effect sleep-related behaviour change; DOZE will contribute to improvements in energy, mood, and perceived quality of life. Exploratory analyses will also be conducted to evaluate which aspects of DOZE participants (AYAs) found most helpful.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Adolescents, Young Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DOZE Users
Arm Type
Experimental
Arm Description
Adolescents and young adults (AYAs) using DOZE for sleep disturbance.
Intervention Type
Other
Intervention Name(s)
DOZE Sleep App
Intervention Description
DOZE is an evidence-based cognitive behavioural therapy for insomnia app created specifically for use with adolescents and young adults.
Primary Outcome Measure Information:
Title
Treatment Evaluation Questionnaire
Description
A quantitative questionnaire consisting of 5 questions evaluating treatment credibility. Scores range from 5 to 35, with higher scores indicating a more favourable evaluation of treatment.
Time Frame
Endpoint (week 4 or later)
Title
Acceptability E-Scale
Description
A quantitative questionnaire, created for the purposes of this study, consisting of 6 questions assessing the acceptability of the app (helpfulness, usefulness, understandability, ease of use, enjoyment, and overall satisfaction) using a 5-point Likert scale. Scores range from 5 to 30, with higher scores indicating greater acceptability of the app.
Time Frame
Endpoint (week 4 or later)
Title
Qualitative Assessment: Post-Test
Description
A qualitative questionnaire, created for the purposes of this study, consisting of 4 open-ended questions to obtain feedback on the app. Because of its qualitative nature, no scores are associated with this outcome; rather, this assessment will be used to receive open-ended feedback from the participants about the aspects of the app that they did and did not like.
Time Frame
Endpoint (week 4 or later)
Secondary Outcome Measure Information:
Title
Google Analytics: time spent on each app page
Description
Google Analytics will be used to track the time spent by each participant on each page/area of the app. This information will be used qualitatively to understand which aspects of the app were found least/most helpful.
Time Frame
Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Title
Google Analytics: number of times app logged in
Description
Google Analytics will be used to track the number of times each participant logged into the app. Greater adherence to app use (and daily sleep tracking) indicates greater acceptability of the app.
Time Frame
Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Title
Google Analytics: number of times app used
Description
Google Analytics will be used to track the number of times participants used the app. Greater app use indicates greater acceptability of the app. Google Analytics will provide a count of the number of times the app was accessed.
Time Frame
Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Title
Google Analytics: number of quizzes completed
Description
Google Analytics will be used to track the number of quizzes each participant completed. Quizzes are included in the app under the "Tips" heading, and include questions that related to chronotype, difficulty winding down, difficulty getting up, sleep drunkenness, trouble staying awake, and fatigue. Quizzes are an optional feature of the app which are used to provide participants with psychoeducation about these topics and how they relate to symptoms of sleep disturbance.
Time Frame
Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Title
Sleep diary parameters
Description
Data extracted from sleep diaries, including variability in bedtime, variability in rise time, total sleep time, total time in bed, sleep onset latency, wake after sleep onset, number of awakenings, naps
Time Frame
Everyday for duration of study participation (i.e., week 0 to week 4 or later)
Title
Center for Epidemiological Studies Depression Scale-Revised (9 items)
Description
Scores range from 0 to 36, with higher scores indicating more severe depressive symptoms.
Time Frame
Baseline (week 0) and endpoint (week 4 or later)
Title
State-Trait Inventory of Cognitive and Somatic Anxiety
Description
This measure includes two scales: a state scale (with scores ranging from 21 to 84) and a trait scale (with scores ranging from 21 to 84). Higher scores on both scales indicate more severe symptoms of anxiety.
Time Frame
Baseline (week 0) and endpoint (week 4 or later)
Title
Fatigue Severity Scale
Description
A total score is computed by summing all of the items (range: 9 to 63) and dividing the score by the number of items to yield an item average. Average scores range from 1 to 7, with higher average scores indicating more impairment due to fatigue.
Time Frame
Baseline (week 0) and endpoint (week 4 or later)
Title
Cleveland Adolescent Sleepiness Scale
Description
Scores range from 0 to 64, with higher scores indicating greater sleepiness.
Time Frame
Baseline (week 0) and endpoint (week 4 or later)
Title
Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
Description
Assesses health-related quality of life using 8 subscales: vitality, physical functioning, bodily pain, general, health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. Items in which higher scores indicate better functioning are reverse scored when creating subscale scores. Subscale scores are converted to T scores ranging from 0 to 100, with higher scores indicating worse functioning.
Time Frame
Baseline (week 0) and endpoint (week 4 or later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 15 and 24 years Experiencing sleep disturbance Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olya Bogouslavsky, MPH
Phone
4169795000
Ext
2185
Email
olya@arts.ryerson.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole E Carmona, BSc
Phone
4169795000
Ext
2185
Email
nicole.carmona@psych.ryerson.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen E Carney, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ryerson University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B2K3
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Carney, PhD
Phone
416-979-5000
Ext
2177
Email
ccarney@ryerson.ca
First Name & Middle Initial & Last Name & Degree
Olya Bogouslavsky, MPH
Phone
416-979-5000
Ext
2185
Email
olya@ryerson.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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21257344
Citation
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PubMed Identifier
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Citation
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Results Reference
derived

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DOZE Sleep App for Youth With Sleep Disturbance

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