More Sleep for Pain Management

Overseen By Margeaux Gray, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Must not be taking: Sleep medications, Pain medications

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

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

Compensation: Varies

Number of Visits: 2

45 Participants Needed

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

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.

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

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

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Findings from Research

A cognitive behavioral pain management program significantly improved sleep quality in patients with chronic pain, particularly reducing the number of wake bouts, as shown by a large treatment effect (d = 0.76) compared to a waiting list control group.

The study involved 46 participants (24 in the intervention group and 22 in the control group) and utilized both self-reported and objective sleep measures, indicating that cognitive behavioral therapy may be a beneficial approach for addressing sleep disturbances in chronic pain patients.

NCBI (Pubmed)

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. Blake, C., Cunningham, J., Power, CK., et al.[2018]

A review of 19 studies on patient-reported outcome measures (PROMs) for assessing sleep quality in adults with pain-related conditions found that the Jenkins Sleep Scale (JSS), Pittsburgh Sleep Quality Scale (PSQI), and Medical Outcomes Study-Sleep Scale (MOS-SS) were the most frequently evaluated, highlighting their relevance in this context.

The review indicated that while the JSS and MOS-SS showed sufficient content and structural validity, there is still a need for further investigation into the reliability and responsiveness of these measures, particularly in chronic pain conditions.

NCBI (Pubmed)

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. Phelps, C., Bellon, S., Hinkey, M., et al.[2021]

The feasibility trial involving 25 adults with chronic pain and insomnia showed that 64% of participants completed all sessions of the Hybrid CBT, indicating a reasonable level of adherence to this intensive therapy.

Qualitative feedback from participants revealed satisfaction with the Hybrid CBT content, but suggested improvements such as reducing session length and increasing therapist contact, which could enhance adherence in future trials.

NCBI (Pubmed)

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. Tang, NKY., Moore, C., Parsons, H., et al.[2021]

The Chronic Pain Sleep Inventory (CPSI) was validated in a study involving 2674 patients with chronic pain, showing that it effectively measures sleep problems related to pain, particularly through three key items.

The CPSI demonstrated strong construct validity and reliability, indicating it can reliably assess sleep issues in chronic pain patients, which may help in evaluating treatment outcomes for pain relief and its impact on sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric testing and validation of the Chronic Pain Sleep Inventory. Kosinski, M., Janagap, CC., Gajria, K., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improves sleep quality in adults with chronic pain, with a strong effect size observed in a meta-analysis of 9 studies involving 385 participants.

While CBT-I also helps reduce pain, anxiety, and depression post-treatment, the long-term benefits are unclear, and sleep hygiene interventions were found to be ineffective in comparison.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of non-pharmacological sleep interventions for people with chronic pain: a systematic review and meta-analysis. Whale, K., Dennis, J., Wylde, V., et al.[2022]

In a study of 38 adults with sleep duration less than 7 hours, the combination of a Fitbit and coaching showed potential for improving sleep duration, although the results were not statistically significant compared to a self-management control group.

Coaching alone led to significant improvements in sleep-related impairment, highlighting that while all interventions were feasible and acceptable, the added accountability from coaching may enhance the effectiveness of sleep extension strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study to understand the components of behavioral sleep extension. Baron, KG., Trela-Hoskins, SR., Duffecy, J., et al.[2023]

In a study involving 90 patients with severe chronic back pain, the use of an adjustable airbed for 28 nights resulted in significant improvements, with 95% of participants reporting reduced pain and 88% experiencing better sleep quality.

The adjustable airbed was preferred by 85% of participants, and it showed substantial benefits in health status measures, indicating it could be an effective adjunct to traditional therapies for managing chronic back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term outcomes of chronic back pain patients on an airbed vs innerspring mattresses. Monsein, M., Corbin, TP., Culliton, PD., et al.[2015]

The Pain Sleep questionnaire (PS-20) was developed and validated for measuring pain-related sleep disturbances in 125 pain clinic patients, demonstrating excellent internal consistency with a Cronbach's alpha of 0.969.

The PS-20 effectively correlates with physical health measures, indicating its reliability and validity as a tool for assessing how pain affects sleep quality in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development and evaluation of a patient-reported outcome measure of pain-related sleep disturbances for pain clinic patients]. Morita, Y., Iseki, M., Ifuku, M., et al.[2022]

Sleep deprivation is linked to a range of serious health issues, including mental health problems, obesity, and chronic diseases, with a particularly strong connection to chronic pain and musculoskeletal conditions.

Between 67% and 88% of individuals with chronic pain experience sleep disruptions, indicating that improving sleep quality could significantly benefit their pain management and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Importance of Sleep for People With Chronic Pain: Current Insights and Evidence. Whale, K., Gooberman-Hill, R.[2022]

In a study of 27 healthy individuals, extending sleep by an average of 2 hours per night increased pain tolerance beyond baseline levels, indicating that more sleep can help people handle pain better.

However, while sleep extension did not change pain threshold, those who typically get less sleep than they need (lower sleep credit) showed greater improvements in pain tolerance, suggesting that sleep debt may significantly affect how we experience pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep extension reduces pain sensitivity. Simonelli, G., Mantua, J., Gad, M., et al.[2022]

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]

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]

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]

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

Psychometric testing and validation of the Chronic Pain Sleep Inventory. [2022]

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]

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

A feasibility study to understand the components of behavioral sleep extension. [2023]

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

Short-term outcomes of chronic back pain patients on an airbed vs innerspring mattresses. [2015]

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]

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

The Importance of Sleep for People With Chronic Pain: Current Insights and Evidence. [2022]

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

Sleep extension reduces pain sensitivity. [2022]