DOZE Sleep App for Youth With Sleep Disturbance

NCT ID: NCT03960294

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-30

Study Completion Date

2020-03-31

Brief Summary

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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:

1. That participants (AYAs) will find the app satisfactory and credible;
2. DOZE will effect sleep-related behaviour change;
3. 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.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DOZE Users

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

Group Type EXPERIMENTAL

DOZE Sleep App

Intervention Type OTHER

DOZE is an evidence-based cognitive behavioural therapy for insomnia app created specifically for use with adolescents and young adults.

Interventions

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DOZE Sleep App

DOZE is an evidence-based cognitive behavioural therapy for insomnia app created specifically for use with adolescents and young adults.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 15 and 24 years
* Experiencing sleep disturbance

Exclusion Criteria

* None
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toronto Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Colleen Carney

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colleen E Carney, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Locations

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Ryerson University

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Olya Bogouslavsky, MPH

Role: CONTACT

4169795000 ext. 2185

Nicole E Carmona, BSc

Role: CONTACT

4169795000 ext. 2185

Facility Contacts

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Colleen Carney, PhD

Role: primary

416-979-5000 ext. 2177

Olya Bogouslavsky, MPH

Role: backup

416-979-5000 ext. 2185

References

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Gradisar M, Gardner G, Dohnt H. Recent worldwide sleep patterns and problems during adolescence: a review and meta-analysis of age, region, and sleep. Sleep Med. 2011 Feb;12(2):110-8. doi: 10.1016/j.sleep.2010.11.008. Epub 2011 Jan 22.

Reference Type BACKGROUND
PMID: 21257344 (View on PubMed)

Sivertsen B, Harvey AG, Lundervold AJ, Hysing M. Sleep problems and depression in adolescence: results from a large population-based study of Norwegian adolescents aged 16-18 years. Eur Child Adolesc Psychiatry. 2014 Aug;23(8):681-9. doi: 10.1007/s00787-013-0502-y. Epub 2013 Nov 30.

Reference Type BACKGROUND
PMID: 24292341 (View on PubMed)

Hicks RA, Fernandez C, Pellegrini RJ. Striking changes in the sleep satisfaction of university students over the last two decades. Percept Mot Skills. 2001 Dec;93(3):660. doi: 10.2466/pms.2001.93.3.660.

Reference Type BACKGROUND
PMID: 11806582 (View on PubMed)

Yang CM, Wu CH, Hsieh MH, Liu MH, Lu FH. Coping with sleep disturbances among young adults: a survey of first-year college students in Taiwan. Behav Med. 2003 Fall;29(3):133-8. doi: 10.1080/08964280309596066.

Reference Type BACKGROUND
PMID: 15206832 (View on PubMed)

Crowley SJ, Acebo C, Carskadon MA. Sleep, circadian rhythms, and delayed phase in adolescence. Sleep Med. 2007 Sep;8(6):602-12. doi: 10.1016/j.sleep.2006.12.002. Epub 2007 Mar 26.

Reference Type BACKGROUND
PMID: 17383934 (View on PubMed)

Aoki H, Ozeki Y, Yamada N. Hypersensitivity of melatonin suppression in response to light in patients with delayed sleep phase syndrome. Chronobiol Int. 2001 Mar;18(2):263-71. doi: 10.1081/cbi-100103190.

Reference Type BACKGROUND
PMID: 11379666 (View on PubMed)

Mindell JA, Kuhn B, Lewin DS, Meltzer LJ, Sadeh A; American Academy of Sleep Medicine. Behavioral treatment of bedtime problems and night wakings in infants and young children. Sleep. 2006 Oct;29(10):1263-76.

Reference Type BACKGROUND
PMID: 17068979 (View on PubMed)

Owens JA, Rosen CL, Mindell JA. Medication use in the treatment of pediatric insomnia: results of a survey of community-based pediatricians. Pediatrics. 2003 May;111(5 Pt 1):e628-35. doi: 10.1542/peds.111.5.e628.

Reference Type BACKGROUND
PMID: 12728122 (View on PubMed)

Stojanovski SD, Rasu RS, Balkrishnan R, Nahata MC. Trends in medication prescribing for pediatric sleep difficulties in US outpatient settings. Sleep. 2007 Aug;30(8):1013-7. doi: 10.1093/sleep/30.8.1013.

Reference Type BACKGROUND
PMID: 17702271 (View on PubMed)

Boerner KE, Coulombe JA, Corkum P. Barriers and facilitators of evidence-based practice in pediatric behavioral sleep care: qualitative analysis of the perspectives of health professionals. Behav Sleep Med. 2015;13(1):36-51. doi: 10.1080/15402002.2013.838766. Epub 2013 Dec 23.

Reference Type BACKGROUND
PMID: 24364693 (View on PubMed)

Clarke G, Harvey AG. The complex role of sleep in adolescent depression. Child Adolesc Psychiatr Clin N Am. 2012 Apr;21(2):385-400. doi: 10.1016/j.chc.2012.01.006.

Reference Type BACKGROUND
PMID: 22537732 (View on PubMed)

Speth TA, Coulombe JA, Markovich AN, Chambers CT, Godbout R, Gruber R, Hall WA, Reid GJ, Stremler R, Weiss SK, Witmans M, Corkum PV. Barriers, facilitators, and usability of an Internet intervention for children aged 1 to 10 years with insomnia. Translational Issues in Psychological Science 1(1): 16-31, 2015.

Reference Type BACKGROUND

Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872.

Reference Type BACKGROUND
PMID: 22654196 (View on PubMed)

Carmona NE, Usyatynsky A, Kutana S, Corkum P, Henderson J, McShane K, Shapiro C, Sidani S, Stinson J, Carney CE. A Transdiagnostic Self-management Web-Based App for Sleep Disturbance in Adolescents and Young Adults: Feasibility and Acceptability Study. JMIR Form Res. 2021 Nov 1;5(11):e25392. doi: 10.2196/25392.

Reference Type DERIVED
PMID: 34723820 (View on PubMed)

Other Identifiers

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348431

Identifier Type: -

Identifier Source: org_study_id

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