More Sleep: Pain Response to Longer Sleep

Not Applicable

Recruiting

• Conditions: Pain; Sleep
• Interventions: Behavioral: Sleep extension

• Registration Number: NCT05816434
• Lead Sponsor: Penn State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-18
• Study Start: 2024-03-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. 18 to 24 (inclusive) years of age at enrollment
2. Fluent English speaker and reader
3. Willing to refrain from initiating new therapeutic interventions (e.g., medication; behavioral) designed to target sleep or pain for the duration of study participation

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Exclusion Criteria

1. Diagnosed with a sleep disorder
2. Diagnosed with a pain disorder
3. Has experienced a cold-related injury frostbite or has any other nerve damage to the feet
4. Has a history of injury to any of the muscular measurement sites for pain (I.e. shoulder, jaw, forearm)
5. Diagnosed with hypertension or cardiovascular disease
6. Evidence of hypertension
7. Diagnosed serious mental health disorder or substance use disorder
8. Taking any physician-directed pharmacologic intervention for sleep
9. Taking any physician-directed pharmacologic intervention for pain
10. Personal health history of traumatic brain injury
11. Pregnant
12. Current smoker

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Extension	Sleep extension	1 week of \>1 hour increased time in bed

Primary Outcome Measures

Name	Time	Method
Change in thermal pain tolerance from before to after sleep extension	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).	Latency to respond to a bilateral cold pressor test (feet). A longer latency to tolerance indicates better pain response.
Change in pressure pain threshold from before to after sleep extension	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).	Bilateral response to a clinically standard algometer at 3 different physical palpation sites. A higher pressure reading indicates a better pain response.
Change in pain inhibition from before to after sleep extension	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).	Pain inhibition is measured as the difference in pressure pain threshold from before to after cold pressor procedure. A reduction in pressure pain threshold is typical after cold pressor procedure. A greater reduction in pain threshold indicates a better response of the pain inhibitory system.
Change in pressure pain tolerance from before to after sleep extension	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).	Bilateral response to a clinically standard algometer at 3 different physical palpation sites. A higher pressure reading indicates a better pain response.
Change in weekly average of momentary pain self-reports from before to after sleep extension	(averaged) Daily surveys during study week 1 (pre-intervention) and study week 2 (intervention)	Intermittent pain intensity using a Visual Analog Scale (0-100, where 0 = "no pain", 100 = "worst pain imaginable in current circumstances"). Higher values indicated more pain, and a negative change indicates a decrease in pain.
Change in thermal pain threshold from before to after sleep extension	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).	Latency to respond to a bilateral cold pressor test (feet). A longer latency to threshold indicates better pain response.

Trial Locations

Locations (1)

Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States