More Sleep for Pain Management

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Penn State University

Must not be taking: Sleep medications, Pain medications

Disqualifiers: Sleep disorder, Pain disorder, Hypertension, Cardiovascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is being done to find out whether extending sleep for at least an hour per night, seven days a week, predicts a higher tolerance and a higher threshold for pain. This is a 21-day study. Participants will be asked to wear sleep- and heart- monitoring watches. Pressure pain and cold pain will be measured at study visits.

Will I have to stop taking my current medications?

The trial requires that you do not start any new treatments for sleep or pain during the study, but it does not specify if you need to stop current medications. However, if you are taking medications directed by a doctor for sleep or pain, you may not be eligible to participate.

What data supports the effectiveness of the treatment Sleep extension, Sleep Extension Therapy, Extended Sleep Duration for pain management?

Research shows that non-drug treatments aimed at improving sleep can help people with chronic pain sleep better, which might also help manage their pain. ^{1 2 3 4 5}

Is sleep extension therapy safe for humans?

The research does not provide specific safety data for sleep extension therapy, but it generally involves non-invasive methods like using a sleep tracker and coaching, which are typically safe for humans. ^{2 5 6 7 8}

How is the sleep extension treatment different from other treatments for pain management?

Sleep extension is unique because it focuses on increasing sleep duration to reduce pain sensitivity, unlike other treatments that may use medications or cognitive therapies. This approach leverages the natural link between sleep and pain, aiming to improve pain management by addressing sleep deprivation, which is common in people with chronic pain. ^{1 3 5 9 10}

Eligibility Criteria

This trial is for young adults aged 18 to 24 who speak and read English fluently. Participants should not start any new treatments for sleep or pain during the study. They'll need to wear monitoring devices and have their pain tolerance tested.

Inclusion Criteria

I agree not to start any new treatments for sleep or pain during the study.

Fluent English speaker and reader

I am between 18 and 24 years old.

Exclusion Criteria

I have been diagnosed with a sleep disorder.

I have been diagnosed with a condition that causes chronic pain.

I have had frostbite or other nerve damage to my feet.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline

Participants maintain their usual sleep behavior for baseline measurement

1 week

1 visit (in-person)

Intervention

Participants extend sleep by at least an hour per night

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain response and sleep patterns

1 week

Treatment Details

Interventions

• Sleep extension (Behavioral Intervention)

Trial Overview The study tests if sleeping at least one extra hour each night over a three-week period can increase a person's ability to tolerate pain. Pain response will be measured using pressure and cold stimuli in scheduled visits.

Participant Groups

Group I: Sleep Extension Experimental Treatment 1 Intervention

1 week of \>1 hour increased time in bed

Group II: Control Active Control 1 Intervention

Sustained sleep behavior

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Pennsylvania State University University Park, PA

Who Is Running the Clinical Trial?

Penn State University Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

The Impact of a Cognitive Behavioral Pain Management Program on Sleep in Patients with Chronic Pain: Results of a Pilot Study. [2018] To determine the impact of a cognitive behavioral pain management program on sleep in patients with chronic pain.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Measurement properties of Patient-Reported Outcome Measures used to assess the sleep quality in adults with high prevalence chronic pain conditions: a systematic review. [2021] To provide a comprehensive overview of the measurement properties of patient-reported outcome measures (PROMs) used to assess sleep quality in adult patients with prevalent pain-related conditions.

3. England pubmed.ncbi.nlm.nih.gov

Implementing a hybrid cognitive-behavioural therapy for pain-related insomnia in primary care: lessons learnt from a mixed-methods feasibility study. [2021] To test the feasibility of implementing a brief but intensive hybrid cognitive behavioural therapy (Hybrid CBT) for pain-related insomnia.

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

Psychometric testing and validation of the Chronic Pain Sleep Inventory. [2022] Patients with chronic pain often experience significant disruptions in sleep. A potential benefit of treatment aimed at pain relief is improved quality of sleep in patients with chronic pain.

5. England pubmed.ncbi.nlm.nih.gov

The effectiveness of non-pharmacological sleep interventions for people with chronic pain: a systematic review and meta-analysis. [2022] About two thirds of people with chronic pain report problems sleeping. We aimed to evaluate the effectiveness of non-pharmacological sleep interventions for improving sleep in people with chronic pain.

6. Netherlands pubmed.ncbi.nlm.nih.gov

A feasibility study to understand the components of behavioral sleep extension. [2023] The goal of this study was to examine the contribution of sleep extension intervention components (wearable sleep tracker and coaching) on sleep extension outcomes.

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

Short-term outcomes of chronic back pain patients on an airbed vs innerspring mattresses. [2015] To compare SF-36, pain Visual Analog Scale (VAS), and sleep VAS outcomes of an adjustable airbed with innerspring mattresses in a population of chronic back pain sufferers.

8. Japan pubmed.ncbi.nlm.nih.gov

[Development and evaluation of a patient-reported outcome measure of pain-related sleep disturbances for pain clinic patients]. [2022] The purpose of this study was to develop a new tool, the Pain Sleep questionnaire, consisting of 20 items (PS-20) for measuring pain-related sleep disturbances in pain clinic patients, and to examine its reliability and validity.

9. England pubmed.ncbi.nlm.nih.gov

The Importance of Sleep for People With Chronic Pain: Current Insights and Evidence. [2022] We are currently in the midst of a sleep crisis. Our current work and lifestyle environments are normalizing poor sleep with substantial negative impact on our health. Research on sleep has linked sleep deprivation to poorer mental health, obesity, cancer, diabetes, heart disease, and a myriad of other health conditions. Sleep deprivation is an even greater issues for people with musculoskeletal conditions and chronic pain. Between 67% and 88% of individuals with chronic pain experience sleep disruption and insomnia, and at least 50% of people with insomnia report chronic pain. The link between sleep and pain is well documented. Experimental, cohort, and longitudinal studies have all demonstrated that restricted sleep is linked to greater pain. Poor sleep therefore not only affects general health but has a direct impact on inflammation, pain response, and experience. Improving sleep in people living with musculoskeletal conditions and with chronic pain has the potential to deliver great benefit to many. This article describes the evidence base that can underpin such work, including research about the link between pain and sleep as well as theories and approaches to intervention that may help. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

10. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep extension reduces pain sensitivity. [2022] Insufficient sleep increases pain sensitivity in healthy individuals. Additionally, extending sleep (eg, increasing nocturnal sleep time or adding a mid-day nap) has been shown to restore pain sensitivity to baseline levels in sleep deprived/restricted individuals. Whether sleep extension can reduce pain sensitivity beyond baseline levels in non-sleep restricted/deprived individuals remains unknown.