Digital Sleep Medicine for Chronic Pain and Sleep Issues

(YAC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Mandeep Singh, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Women's College Hospital

Disqualifiers: Cancer, Epilepsy, Severe depression, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to test the DOZE app, a digital tool that helps young adults with chronic pain improve their sleep and manage their pain through behavioral changes. The study focuses on young adults aged 18-25 because they often struggle with sleep issues that worsen their pain. The app works by helping users change their sleep habits to feel better overall. DOZE (Delivering Online Zzz's with Empirical Support) is a behavioral, self-management sleep app designed to improve sleep in adolescents and young adults.

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 data supports the effectiveness of the DOZE app treatment for chronic pain and sleep issues?

Research shows that sleep disturbances are common in people with chronic pain, and addressing sleep issues can improve overall well-being. The use of sleep diaries and monitoring tools has been effective in assessing and managing sleep problems, suggesting that digital tools like the DOZE app could help improve sleep quality in chronic pain patients. ^{1 2 3 4 5}

Is the DOZE app safe for use in humans?

The research does not provide specific safety data for the DOZE app or similar digital sleep medicine treatments, but pre-sleep audiovisual alpha entrainment, a related approach, was found to be acceptable and perceived as beneficial by users with chronic pain and sleep disturbances. ^{2 6 7 8 9}

How is the DOZE app treatment different from other treatments for chronic pain and sleep issues?

The DOZE app is unique because it offers a digital, app-based approach to improving sleep for those with chronic pain, potentially using techniques like pre-sleep audio and visual stimulation to enhance brain activity and reduce pain perception, which is different from traditional medication or therapy methods. ^{2 4 10 11 12}

Research Team

Mandeep Singh, MD

Principal Investigator

Women's College Hospital

Eligibility Criteria

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.

Inclusion Criteria

I am 18-25, have chronic pain for over 3 months, a sleep disorder, speak English, and have internet access.

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.

Trial Timeline

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

Treatment Details

Interventions

• DOZE app (Behavioral Intervention)

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.

Participant Groups

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+

Heather McPherson

Women's College Hospital

Chief Executive Officer since 2020

Master of Science in Rehabilitation Science, University of Toronto

Dr. Cindy Maxwell

Women's College Hospital

Chief Medical Officer since 2023

MD, specialization in Maternal Fetal Medicine

Toronto Metropolitan University

Collaborator

Trials

95

Recruited

19,300+

Dr. Mohamed Lachemi

Toronto Metropolitan University

Chief Executive Officer since 2016

PhD in Civil Engineering from L'Université de Sherbrooke

Dr. Patrizia Albanese

Toronto Metropolitan University

Chief Medical Officer

MD from McGill University

Ryerson University

Collaborator

Trials

77

Recruited

7,800+

Edward J. Lehner

Ryerson University

Chief Executive Officer since 2015

Bachelor of Business Administration from the University of Cincinnati

Dr. Samir Sinha

Ryerson University

Chief Medical Officer since 2023

MD from University of Toronto

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of a sleep diary for chronic pain patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Daily diary and ambulatory activity monitoring of sleep in patients with insomnia associated with chronic musculoskeletal pain. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Sleep quality and presleep arousal in chronic pain. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Ambulatory recording and power spectral analysis by autoregressive modelling of polygraphic sleep signals in patients suffering from chronic pain. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Disrupted sleep patterns and daily functioning in patients with chronic pain. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Self-reported sleep and mood disturbance in chronic pain patients. [2022]

7. England pubmed.ncbi.nlm.nih.gov

User experiences of pre-sleep sensory alpha brainwave entrainment for people with chronic pain and sleep disturbance. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Polysomnographic characteristics in nonmalignant chronic pain populations: A review of controlled studies. [2022]

9. United States 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Predicting Poor Sleep Quality in Fibromyalgia with Wrist Sensors. [2021]

11. Switzerland 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. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Does sleep differ among patients with common musculoskeletal pain disorders? [2021]