Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Pain Insomnia Insomnia Due to Medical Condition

Keywords

InsomniaPain

Outcome Measures

Primary Outcomes (4)

Study recruitment/retention
Number of Participants recruited/dropping out of study (accrual/dropout rates)
12 weeks
Study compliance to DOZE app intervention/Sleep diary
Number of Participants completing/using the DOZE app and completing the sleep diary daily during 10 weeks study intervention
10 weeks
Study DOZE app treatment evaluation
Participants' scoring on a 5 point Likert scale pre and post study intervention
12 weeks
Issues and concerns reported via phone calls and emails (Fidelity)
Issues and concerns reported while using the intervention tracked by a research assistant, control strategy or outcome measures will be monitored. Can the intervention, and outcome measures be completed as planned or patient not comply with use.

Secondary Outcomes (4)

Patient reported improvement in pain
12 weeks
Patient reported improvement in Health Related Quality Of Life
12 weeks
Patient reported Global Impression of Change
12 weeks
Patient reported improvement in sleep
12 weeks

Study Arms (1)

Intervention arm

EXPERIMENTAL

A cohort of YAC patients to be studied, pre \& post-intervention, prospectively. All participants will be assigned to the intervention (complete DOZE app: Sleep diary and DOZE modules).

Behavioral: DOZE app

Interventions

DOZE appBehavioral

Complete DOZE app: Delivering Online "ZZZ's with Empirical support (DOZE) app plus a Consensus Sleep Diary (CSD). The DOZE app, is a web-based app optimized for desktop, smartphone, or tablet use. It is a self-management program for adolescents and young adults with sleep problems. The intervention will be delivered on restricted password-protected applications that will allow tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log onto the sleep dairy (via automated alerts) once a day over a 10-week period to complete sleep diary entries, develop and track their goals, and receive sleep health education/tailored sleep health interventions. 1-week pre- and post- intervention, participants will complete a battery of baseline study questionnaires and have the option of using a Geneactiv actigraphy device along with a CSD.

Intervention arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 25 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Young adult patients aged 18 - 25 years old, who have
Non-malignant chronic pain lasting more than 3 months, with

Sponsors & Collaborators

Women's College Hospital
Otherlead
Toronto Metropolitan University
Othercollaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersChronic PainPain

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Mandeep Singh, M.D
Women's College Hospital
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 26, 2021

First Posted

December 7, 2021

The Young Adult Clinic (YAC) Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (4)

Study Arms (1)

Intervention arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (4)

Study Arms (1)

Intervention arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations