Digital Sleep Medicine for Chronic Pain and Sleep Issues

(YAC Trial)

Overseen By Rachel Ortiz

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Women's College Hospital

Disqualifiers: Cancer, Epilepsy, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the DOZE app, designed to assist young adults aged 18-25 who have experienced chronic pain for over three months and face sleep issues. The app provides a digital method for managing sleep problems and pain, enabling participants to track sleep patterns and access helpful modules. Individuals with chronic pain and a sleep disorder who speak English and have a smartphone or computer with internet access may qualify for this trial. As an unphased trial, this study presents a unique opportunity to explore innovative digital solutions for managing chronic pain and sleep issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are involved in other psychological treatments or drug trials during the study.

What prior data suggests that the DOZE app is safe for young adults with chronic pain?

Research has shown that the DOZE app is a safe choice for young adults with sleep problems. Designed with a focus on personal needs and experiences, the app is both user-friendly and effective.

The app helps users understand and improve their sleep habits. As a digital tool, it involves no medication or physical treatments, typically resulting in fewer safety concerns. Users interact with the app to track their sleep and follow suggested changes.

No reports of negative effects from using the app have emerged, but experiences can vary from person to person. Overall, the DOZE app is considered safe and well-tolerated for young adults managing their sleep and chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DOZE app because it offers a novel approach to managing chronic pain and sleep issues through digital therapy, which is a departure from traditional medication or therapy sessions. Unlike standard treatments like prescription sleep aids or pain relievers, the DOZE app incorporates a sleep diary and interactive modules that users can engage with at their own convenience. This method empowers patients to actively participate in their treatment and make data-driven adjustments, potentially leading to more personalized and effective outcomes. Additionally, the app's digital nature allows for consistent tracking and adaptation, which can provide valuable insights into a patient's progress and facilitate ongoing improvements.

What evidence suggests that the DOZE app is effective for chronic pain and sleep issues?

Research shows that the DOZE app might help young adults with chronic pain and sleep difficulties. In this trial, all participants will use the DOZE app, designed to manage sleep with input from young adults. Early results suggest that DOZE can improve sleep by promoting better habits. Testing has confirmed the app's ease of use, indicating its effectiveness. Overall, the DOZE app serves as a helpful tool for managing sleep problems alongside chronic pain. ^{5 6 7 8 9}

Who Is on the Research Team?

Mandeep Singh, MD

Principal Investigator

Women's College Hospital

Are You a Good Fit for This Trial?

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.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the DOZE app, including completing a sleep diary and DOZE modules

10 weeks

Ongoing app usage and self-reporting

Follow-up

Participants are monitored for improvements in pain, sleep, and quality of life

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DOZE app

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

Toronto Metropolitan University

Collaborator

Trials

95

Recruited

19,300+

Ryerson University

Collaborator

Trials

77

Recruited

7,800+

Published Research Related to This Trial

The study involved 40 subjects with insomnia linked to chronic musculoskeletal pain, using both sleep diaries and actigraphy to assess sleep disturbances, revealing that pain severity was strongly associated with reported sleep impairment.

While both assessment methods provided similar estimates for total sleep time and sleep efficiency, they differed in measuring sleep onset latency and nocturnal awakenings, highlighting the need for multi-method assessments in understanding insomnia in chronic pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily diary and ambulatory activity monitoring of sleep in patients with insomnia associated with chronic musculoskeletal pain. Wilson, KG., Watson, ST., Currie, SR.[2022]

Chronic musculoskeletal pain significantly disrupts sleep quality, creating a vicious cycle where pain and sleep issues exacerbate each other, but specific sleep variables affected by pain are hard to quantify.

Comorbid conditions like fatigue, depression, and anxiety complicate the understanding of sleep disturbances in chronic pain patients, highlighting the need for more targeted research to improve clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does sleep differ among patients with common musculoskeletal pain disorders? Lavigne, GJ., Nashed, A., Manzini, C., et al.[2021]

In a study of 51 chronic pain patients, 88% reported experiencing sleep complaints, highlighting a significant issue among this population.

The research found that presleep cognitive arousal, rather than the severity of pain, was the main factor predicting sleep quality, suggesting that addressing mental factors may improve sleep in chronic pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep quality and presleep arousal in chronic pain. Smith, MT., Perlis, ML., Smith, MS., et al.[2022]

A study involving 27 participants with chronic pain and sleep disturbances found that pre-sleep audiovisual alpha entrainment using a smartphone program was well-accepted and perceived to provide symptomatic benefits.

Participants reported positive experiences regarding the relationship between their pain and sleep, indicating that this method may help improve their overall sleep quality and manage pain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User experiences of pre-sleep sensory alpha brainwave entrainment for people with chronic pain and sleep disturbance. Halpin, SJ., Tang, NK., Casson, AJ., et al.[2023]

In a study of 105 chronic pain patients, 65% reported sleep disturbances, indicating that sleep issues are common in this population.

Poor sleepers experienced higher pain intensity and unpleasantness compared to good sleepers, but there was no significant difference in levels of anxiety or depression between the two groups, suggesting that sleep disturbances may occur independently of mood disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported sleep and mood disturbance in chronic pain patients. Morin, CM., Gibson, D., Wade, J.[2022]

Chronic pain and sleep disturbances are closely linked, with sleep deprivation potentially increasing pain sensitivity due to shared biological mechanisms, but the review of 29 polysomnography studies found no consistent patterns of sleep disturbances in chronic pain patients compared to controls.

While some studies reported alterations in sleep continuity, such as increased light sleep, changes in sleep architecture like slow-wave sleep were inconsistent, highlighting the need for better research methods to understand the relationship between sleep and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polysomnographic characteristics in nonmalignant chronic pain populations: A review of controlled studies. Bjurstrom, MF., Irwin, MR.[2022]

The Dreem 2 sleep monitoring headband, which uses EEG technology, was found to be feasible and acceptable for measuring sleep in a study of 21 adults with chronic pain, with 90% of participants successfully recording sleep data for at least two nights.

Most participants (76%) reported satisfaction with the headband, indicating it could be a valuable tool for screening and monitoring sleep issues in clinical settings, despite the common sleep disturbances associated with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the feasibility and acceptability of a sleep wearable headband among a community sample of chronic pain individuals: An at-home observational study. Zambelli, Z., Jakobsson, CE., Threadgold, L., et al.[2022]

The portable digital recording system and Nightingale sleep analyser allow for high-quality, at-home sleep monitoring in patients with chronic pain, making the process more natural and cost-effective.

Analysis revealed that patients with non-specific chronic pain have significantly higher alpha power relative to delta power during sleep, indicating potential differences in sleep-wakefulness processes compared to healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory recording and power spectral analysis by autoregressive modelling of polygraphic sleep signals in patients suffering from chronic pain. Nielsen, KD., Drewes, AM., Svendsen, L., et al.[2017]

A smartphone program using audio or visual stimulation for alpha entrainment showed feasibility in a study with 28 participants, leading to significant improvements in sleep duration, sleep onset, and sleep efficiency over 4 weeks.

Participants also reported a slight reduction in nighttime pain and improvements in overall sleep quality, pain interference, fatigue, and symptoms of depression and anxiety, indicating potential benefits for managing chronic pain and sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of pre-sleep audio and visual alpha brain entrainment for people with chronic pain and sleep disturbance. Halpin, SJ., Casson, AJ., Tang, NKY., et al.[2023]

In a study of 287 chronic pain patients, 88.9% reported experiencing disturbed sleep, highlighting a significant issue affecting this population.

The research found that sleep disturbance not only correlates with greater pain and disability but also independently predicts these issues, suggesting that improving sleep could enhance daily functioning and reduce suffering in chronic pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disrupted sleep patterns and daily functioning in patients with chronic pain. McCracken, LM., Iverson, GL.[2022]

A wearable device measuring blood volume pulse (BVP) and electrodermal activity (EDA) can help differentiate between individuals with fibromyalgia experiencing poor sleep and those in a control group with refreshing sleep.

Using advanced machine learning techniques, the study achieved a mean Area Under the Curve (AUC) of around 0.65, indicating a moderate ability to classify sleep quality based on these physiological measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Poor Sleep Quality in Fibromyalgia with Wrist Sensors. Alge, O., Reza Soroushmehr, SM., Gryak, J., et al.[2021]

The Daily Sleep Diary (DSD) is a reliable tool for monitoring sleep in chronic pain patients, showing significant correlations with other sleep measures and demonstrating good psychometric properties based on data from 46 patients.

Chronic pain severity and duration negatively impact sleep quality, with findings indicating that higher pain levels are associated with fewer hours of sleep and delayed sleep onset, highlighting the need to address sleep issues in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a sleep diary for chronic pain patients. Haythornthwaite, JA., Hegel, MT., Kerns, RD.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34723820/

A Transdiagnostic Self-management Web-Based App for ... We involved AYAs in the co-design of a behavioral, self-management, transdiagnostic sleep app called DOZE (Delivering Online Zzz's with ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05147974

NCT05147974 | The Young Adult Clinic (YAC) Study 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8694239/

A Transdiagnostic Self-management Web-Based App for ... We involved AYAs in the co-design of a behavioral, self-management, transdiagnostic sleep app called DOZE (Delivering Online Zzz's with Empirical Support).

4. researchgate.net researchgate.net/figure/Flowchart-of-participants-DOZE-Delivering-Online-Zzzs-with-Empirical-Support_fig2_354557402

Flowchart of participants. DOZE: Delivering Online Zzz's ... This is a topical review of assessment and treatment approaches to promote sleep health in children and adolescents with chronic pain, which summarizes: ...

5. researchgate.net researchgate.net/publication/346592319_Improving_Access_and_Outcomes_for_Young_Adult_Sleepers_Results_from_a_Feasibility_Trial_of_an_Evidence-Based_App_for_Sleep_Disturbance_Preprint

Improving Access and Outcomes for Young Adult Sleepers ... sleep app called Delivering Online Zzz's with Empirical support (DOZE). OBJECTIVE The primary objective was to test the feasibility and ...

6. scientia.global scientia.global/dr-colleen-carney-the-doze-app-a-unique-approach-to-overcoming-sleep-problems-in-young-adults/

Dr Colleen Carney - The DOZE App: A Unique Approach to ... Dr Carney has recently turned her expertise to the development of an innovative app to alleviate sleep problems in teenagers and young adults.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11565086/

Using the Person-Based Approach to Co-Create and ... The Sleep Solved app uses science-based advice to improve sleep-related behaviors and well-being. The app was developed using the person-based approach.

8. researchgate.net researchgate.net/profile/Nicole-Carmona

Nicole CARMONA | Clinical Fellow | Doctor of Philosophy DOZE: Delivering Online Zzz's with... Figure 3. Users of Delivering Online Zzz's with Empirical Support by... Participants' responses on the Treatment ...

9. dozeapp.ca dozeapp.ca/

DOZe – delivering online z's – Helping young adults get a ... doze is a research-derived and validated, tailored for individual sleep concerns, doze enables youth to better understand their sleep patterns and make changes ...