InsomniaYACNCT05147974

The Young Adult Clinic (YAC) Study

A study testing DOZE app in people with Insomnia and Chronic Pain, run by Women's College Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The overarching aim of the Young Adult Clinic (YAC) study is to evaluate the DOZE app, a digital, transdiagnostic behavioral sleep medicine and self-management approach in young adult patients (ages 18-25) with chronic pain. Read more about this study

Who is it for?: Ages 18 to 25 years
Conditions the study is for: Insomnia, Chronic Pain, Insomnia Due to Medical Condition
What is being tested?: DOZE app
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteCanada
Study dates: 20 Apr 2023to 2 Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Young adult patients aged 18 - 25 years old, who have
Non-malignant chronic pain lasting more than 3 months, with
Clinically assessed as having a sleep disorder
English speaking with
Access to a mobile phone or a computer with internet access.

Who cannot join

Patients who require urgent CBT treatment as per their health care provider
Patients who have received CBT in the past 3 months
Patients participating in other psychological treatments and/or drug trials during the study
Patients who have other significant medical conditions- Life threatening (e.g. cancer), neurological conditions (e.g. epilepsy)
Patients who have other significant psychiatric conditions-Severe depression or active suicide intent
Situations resulting in forced sleep disruption or derangement of sleep schedule such as night shift work > 2 nights per week in the past 3months

Show all 9Show fewer

Pregnancy or breastfeeding.
Inability to communicate with health care providers or the research personnel
Inability to fill out self-report questionnaires, study materials, or follow instructions.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Women's College Hospital
Toronto, Ontario, M5S 1B2

Other trials in Canada

About this study

Official title: Evaluating the Effectiveness of a Self-management Transdiagnostic Cognitive, Behavioral, Circadian Treatment on Patient Centered Outcomes Such as Self-efficacy, Pain Control and Overall Quality of Life in the Young Adult Chronic Pain Population

Read the detailed description

Sleep, activity, and pain interactions have the potential to impact almost all important protective and regulatory processes in the body. Long-term sleep disruption is associated with increased pain sensitivity, prolonged pain duration, and development of chronic pain. Degree of pain relief can directly impact the quality and disruption of sleep, mood, behavior, social participation, and has a devastating impact on Health Related Quality of Life (HRQL).

Transdiagnostic behavioral sleep medicine and self-management is a behavioral modification approach and is currently a frontline therapy like Cognitive behavioral therapy for insomnia (CBTi) in adults with sleep disorders. However, it is still in early stages of development for adolescent and young adult populations, and less so for youth with co-morbid mental and physical health conditions and chronic pain.

Primary aim: Assess the feasibility of implementing the DOZE app.

Secondary aim:

To examine the variance in effectiveness outcomes, including sleep health, pain, and overall Health Related Quality of Life (HRQL).
To determine the required sample size for a future definitive trial.

Conditions: Insomnia, Chronic Pain, Insomnia Due to Medical Condition
Being tested: DOZE app
Keywords: Insomnia, Pain
Medical subject headings: Sleep Initiation and Maintenance Disorders, Chronic Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DOZE appBehavioural
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.

Study groups in NCT05147974
Study group	Role	What they receive
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). Receives: Behavioral: DOZE app

What is being measured

The primary outcome is the main question the study is designed to answer.

Study recruitment/retention
Number of Participants recruited/dropping out of study (accrual/dropout rates)
Measured: 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
Measured: 10 weeks
Study DOZE app treatment evaluation
Participants' scoring on a 5 point Likert scale pre and post study intervention
Measured: 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.
Measured: 12 weeks

Secondary outcomes (4)

Patient reported improvement in pain
Number of Participants reporting Pain Inventory on a brief pain inventory scale of 0 to10.
Measured: 12 weeks
Patient reported improvement in Health Related Quality Of Life
Assessment of pain disability and intensity.PROMIS-29 A 29 item Questionnaire to assets physical, mental and social health and wellbeing.
Measured: 12 weeks
Patient reported Global Impression of Change
Number of Participants reporting an improvement in PGIC in Questionnaire. It comprises 2 scales: PGIC has a 7-point scale depicting a patient's rating of overall improvement (from 1- worse/no change to 7- greatly better/considerable improvement; and a 10-point likert scale rating of efficacy of treatment (where 0- is much better and 10- is much worse).
Measured: 12 weeks
Patient reported improvement in sleep
Adolescent sleep hygiene scale- 28 item self reported questionnaire Never (0%) Once in a while (20%) Sometimes (40%) Quite often (60%) Frequently, but not always (80%) Always (100%)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 20232 Mar 2026

First posted7 Dec 2021
Study start20 Apr 2023
Primary completion1 Aug 2025
Study completion2 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: This is a clinical trial as the DOZE app intervention is being assessed for improving outcomes in the YAC patient population. We propose a cohort of the 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). Optional Actigraphy device use for measuring physical activity, sedentary behavior, sleep health parameters.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05147974
Sponsor's protocol ID: 2021-0075-B
Acronym: YAC
Status last verified: Apr 2026
First submitted: 26 Nov 2021
Last updated: 23 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Effectiveness of a Self-management Transdiagnostic Cognitive, Behavioral, Circadian Treatment on Patient Centered Outcomes Such as Self-efficacy, Pain Control and Overall Quality of Life in the Young Adult Chronic Pain Population
ClinicalTrials.gov ID: NCT05147974
Acronym / sponsor ID: YAC / 2021-0075-B
Conditions: Insomnia, Chronic Pain, Insomnia Due to Medical Condition
Keywords: Insomnia, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Women's College HospitalUniversity, hospital or other
Collaborators: Toronto Metropolitan University
Study start: 20 Apr 2023 (actual)
Primary completion: 1 Aug 2025 (actual)
Study completion: 2 Mar 2026 (actual)
First posted: 7 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary aim: Assess the feasibility of implementing the DOZE app.

Secondary aim:

To examine the variance in effectiveness outcomes, including sleep health, pain, and overall Health Related Quality of Life (HRQL).
To determine the required sample size for a future definitive trial.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a clinical trial as the DOZE app intervention is being assessed for improving outcomes in the YAC patient population. We propose a cohort of the 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). Optional Actigraphy device use for measuring physical activity, sedentary behavior, sleep health parameters.

Arm	Type	Receives
Intervention arm	Experimental	Behavioral: DOZE appA 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).

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Young adult patients aged 18 - 25 years old, who have
Non-malignant chronic pain lasting more than 3 months, with
Clinically assessed as having a sleep disorder
English speaking with
Access to a mobile phone or a computer with internet access.

Key exclusion criteria (9 listed)

Patients who require urgent CBT treatment as per their health care provider
Patients who have received CBT in the past 3 months
Patients participating in other psychological treatments and/or drug trials during the study
Patients who have other significant medical conditions- Life threatening (e.g. cancer), neurological conditions (e.g. epilepsy)
Patients who have other significant psychiatric conditions-Severe depression or active suicide intent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DOZE appComplete 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.	Behavioural	Intervention arm

Primary outcome

Study recruitment/retention
Time frame: 12 weeks
Number of Participants recruited/dropping out of study (accrual/dropout rates)
Study compliance to DOZE app intervention/Sleep diary
Time frame: 10 weeks
Number of Participants completing/using the DOZE app and completing the sleep diary daily during 10 weeks study intervention
Study DOZE app treatment evaluation
Time frame: 12 weeks
Participants' scoring on a 5 point Likert scale pre and post study intervention
Issues and concerns reported via phone calls and emails (Fidelity)
Time frame: 12 weeks
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.

4 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mandeep Singh, M.D principal investigator

Women's College Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DOZE app in people with Insomnia and Chronic Pain, run by Women's College Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study recruitment/retention (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05147974.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.