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Behavioral Intervention
Digital Sleep Medicine for Chronic Pain and Sleep Issues (YAC Trial)
N/A
Recruiting
Led By Mandeep Singh, M.D
Research Sponsored by Women's College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
YAC Trial Summary
This trial is testing whether a digital sleep medicine and self-management approach can help young adults with chronic pain.
Who is the study for?
The YAC study is for young adults aged 18-25 with chronic non-cancer pain and sleep disorders. Participants must speak English and have access to a mobile phone or internet-connected computer. Excluded are those with night shifts, recent CBT treatment, other significant medical or psychiatric conditions, pregnancy, breastfeeding, or inability to follow the study protocol.Check my eligibility
What is being tested?
This trial evaluates the DOZE app designed to help manage sleep problems in young adults with chronic pain. The app offers digital behavioral sleep medicine techniques aiming at self-management of their condition.See study design
What are the potential side effects?
Since the intervention involves using an app for managing sleep issues rather than medication, there may not be direct side effects like drugs; however, users might experience frustration if they do not see improvements or find it challenging to engage with the technology.
YAC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Issues and concerns reported via phone calls and emails (Fidelity)
Study DOZE app treatment evaluation
Study compliance to DOZE app intervention/Sleep diary
+1 moreSecondary outcome measures
Patient reported Global Impression of Change
Patient reported improvement in Health Related Quality Of Life
Patient reported improvement in pain
+1 moreYAC Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
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).
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Who is running the clinical trial?
Toronto Metropolitan UniversityOTHER
84 Previous Clinical Trials
10,927 Total Patients Enrolled
1 Trials studying Chronic Pain
Women's College HospitalLead Sponsor
101 Previous Clinical Trials
39,087 Total Patients Enrolled
3 Trials studying Chronic Pain
40 Patients Enrolled for Chronic Pain
Ryerson UniversityOTHER
76 Previous Clinical Trials
7,859 Total Patients Enrolled
1 Trials studying Chronic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious medical condition like cancer or epilepsy.I have undergone cognitive behavioral therapy in the last 3 months.My doctor says I urgently need cognitive behavioral therapy.You are currently involved in other therapy or medical studies.You have severe depression or are actively thinking about hurting yourself.You have worked night shifts for more than 2 nights per week in the past 3 months, which has disrupted your sleep schedule.I am 18-25, have chronic pain for over 3 months, a sleep disorder, speak English, and have internet access.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who should be considered an eligible participant in this research endeavor?
"This medical trial is in need of 40 participants, aged 18-25 years old, who have a DSM-V diagnosis for insomnia and are suffering from chronic pain that has persisted for at least 3 months. Additionally, all potential enrollees must possess access to either mobile phones or computers with internet connection."
Answered by AI
Are there any vacant slots for participants in this experiment yet?
"Per the information on clinicaltrials.gov, this medical study is not presently enrolling participants. Initially posted on May 1st 2022, with the latest revision made 9 days later, patients are not being recruited for this trial currently; however there are 622 other studies actively seeking volunteers."
Answered by AI
Are participants above the age of thirty eligible for inclusion in this experiment?
"The age criteria for this investigation stipulates that participants must be under 25 years old and of legal age."
Answered by AI
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