More Sleep: Pain Response to Longer Sleep

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Sleep
• Intervention / Treatment: Behavioral: Sleep extension

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Marie Chang, PhD; Phone Number: +18148635226; Email: auc35@psu.edu
• Study Contact Backup: Name: Margeaux Gray, PhD; Phone Number: +18148635800; Email: mmg58@psu.edu

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Recruiting
      • Pennsylvania State University
      • Contact: Anne-Marie Chang; Phone Number: 814-343-1928; Email: MoreSleep@psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Extension; 1 week of >1 hour increased time in bed	Behavioral: Sleep extension; >1 hour additional time in bed per night for 1 week.
No Intervention: Control; Sustained sleep behavior

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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)
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).
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).
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).

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00022196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The data will be shared within one year after the first publication related to primary outcomes.
• IPD Sharing Access Criteria: Request for data should be made in writing to the PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No