More Sleep: Pain Response to Longer Sleep

• Sponsor: Penn State University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05816434
• Collaborator: (none)
• Enrollment: 45
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep; Pain	Behavioral: Sleep extension	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Can More Sleep Improve Pain Responses, Symptomatology, and Regulation in College Students?
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Apr 30, 2024
• Anticipated Study Completion Date: Apr 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Penn State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne-Marie Chang, Associate Professor, Penn State University
• ClinicalTrials.gov Identifier: NCT05816434
• Other Study ID Numbers: STUDY00022196
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 18, 2023