More Sleep: Pain Response to Longer Sleep

Pain Clinical Trial

Official title:

Can More Sleep Improve Pain Responses, Symptomatology, and Regulation in College Students?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816434
• Other study ID #: STUDY00022196
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: Penn State University
• Contact: Anne-Marie Chang, PhD
• Phone: +18148635226
• Email: auc35[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pain
• Sleep

Intervention

Behavioral:
• Sleep extension
>1 hour additional time in bed per night for 1 week.

Locations

Country	Name	City	State
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pressure pain threshold from before to after sleep extension	Bilateral response to a clinically standard algometer at 3 different physical palpation sites. A higher pressure reading indicates a better pain response.	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).
Primary	Change in pressure pain tolerance from before to after sleep extension	Bilateral response to a clinically standard algometer at 3 different physical palpation sites. A higher pressure reading indicates a better pain response.	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).
Primary	Change in weekly average of momentary pain self-reports from before to after sleep extension	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.	(averaged) Daily surveys during study week 1 (pre-intervention) and study week 2 (intervention)
Primary	Change in thermal pain threshold from before to after sleep extension	Latency to respond to a bilateral cold pressor test (feet). A longer latency to threshold indicates better pain response.	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).
Primary	Change in thermal pain tolerance from before to after sleep extension	Latency to respond to a bilateral cold pressor test (feet). A longer latency to tolerance indicates better pain response.	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).
Primary	Change in pain inhibition from before to after sleep extension	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.	Momentary at study visit 2 (at the end of week1) and a week later at study visit 3 (at the end of week2).