What side effects are associated with this type of intervention?

Common treatments for chronic pain include pharmacologic options like antidepressants, opioids, and acetaminophen, as well as non-pharmacologic approaches such as cognitive behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and exercise. Antidepressants can cause side effects like nausea, weight gain, and sleep disturbances. Opioids may lead to constipation, drowsiness, and the risk of dependency. Acetaminophen is generally well-tolerated but can cause liver damage if taken in high doses. Non-pharmacologic treatments like CBT and MBSR are generally safe but may initially increase anxiety or discomfort as patients confront their pain. Exercise can sometimes lead to muscle soreness or injury if not done properly.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic pain, including pharmacologic options like acetaminophen, NSAIDs, and certain antidepressants (e.g., duloxetine, venlafaxine) for neuropathic pain. Additionally, non-pharmacologic treatments such as cognitive-behavioral therapy (CBT) and other behavioral interventions have been recognized for their efficacy in managing chronic pain. While specific digital and transdiagnostic behavioral sleep medicine approaches like the DOZE app are still under study, the FDA has shown interest in digital health solutions, approving apps and devices for conditions like insomnia and mental health, which are often comorbid with chronic pain.

What other types of research exist?

Promising alternatives to the DOZE app for chronic pain patients include: 1) Cognitive Behavioral Therapy for Insomnia (CBT-I), which can be delivered face-to-face or online and has shown significant improvements in sleep-related quality of life and insomnia symptoms. 2) Mindfulness-Based Stress Reduction (MBSR), which has been effective in reducing chronic pain and improving psychological well-being. 3) New pharmacological agents targeting nerve growth factor, which are under investigation for their potential to provide pain relief. These alternatives offer a combination of behavioral and pharmacological approaches to manage chronic pain effectively.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Issues and concerns reported via phone calls and emails (Fidelity)

Study DOZE app treatment evaluation

Study compliance to DOZE app intervention/Sleep diary

+1 more

Secondary study objectives

Patient reported Global Impression of Change

Patient reported improvement in Health Related Quality Of Life

Patient reported improvement in pain

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic pain, such as cognitive behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and exercise therapy, work by addressing both psychological and physical aspects of pain. CBT helps reframe negative thoughts and behaviors, reducing perceived pain intensity. MBSR increases awareness and acceptance of pain, decreasing stress and improving pain management. Exercise therapy enhances physical function and reduces pain through strengthening and conditioning. These methods are vital for chronic pain patients as they provide sustainable, non-invasive pain management options, improving quality of life and reducing medication dependence.

Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.Cancer pain: part 1: Pathophysiology; oncological, pharmacological, and psychological treatments: a perspective from the British Pain Society endorsed by the UK Association of Palliative Medicine and the Royal College of General Practitioners.