More Sleep: Pain Response to Longer Sleep

NCT05816434 | Completed

• 1 other identifier: STUDY00022196
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Pain

Outcome Measures

Primary Outcomes (6)

• 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).

Study Arms (2)

Sleep Extension

EXPERIMENTAL

1 week of \>1 hour increased time in bed

Behavioral: Sleep extension

Control

NO INTERVENTION

Sustained sleep behavior

Interventions

Sleep extension BEHAVIORAL

\>1 hour additional time in bed per night for 1 week.

Sleep Extension

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 18, 2023
• Study Start: March 18, 2024
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be shared within one year after the first publication related to primary outcomes.
• Access Criteria: Request for data should be made in writing to the PI.

Locations

US (1)