Fragmented Sleep, Pain, and Biomechanics

NCT ID: NCT06336109

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-26
• Study Completion Date: 2025-09-01

Brief Summary

This interventional study aims to test the effects of sleep disruption on pain sensitivity and biomechanics in healthy individuals during experimental knee and shoulder pain. The main question the study aims to answer is:

1) Does sleep fragmentation increase experimental knee and shoulder pain and what are the underlying mechanisms?

Participants will receive two injections a) Hypertonic saline (painful) in the knee and b) hypertonic saline (painful) in the upper arm.

Detailed Description

This study will include healthy participants for one baseline session and one follow-up session separated by three nights of experimental sleep disruption.

The sleep fragmentation will involve three forced awakenings per night for three consecutive nights between sessions. These awakenings will be planned at 00:00, 02:30, and 05:00.

In each session, the participant will answer questionnaires and have their pain sensitivity assessed using cuff-pressure algometry. Following this, they will first receive a painful saline injection into the infrapatellar fat pad of the knee. After a washout period, they will receive another painful saline injection into the deltoid muscle of the shoulder. For both injections, the pain will be rated on an NRS scale (0 representing 'no pain' and 10 representing 'worst pain imaginable') every 30 seconds, and the distribution will be marked on a body chart.

Conditions

Pain; Healthy; Sleep Disturbance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experimental Knee Pain and Shoulder Pain

Injection to the infrapatellar fat pad. Will always be administered first.

Injection to the deltoid muscle. Will always be administered last.

Group Type: EXPERIMENTAL

Hypertonic saline knee and shoulder injection

Intervention Type: OTHER

0.25 mL injection with hypertonic saline (7%) in the infrapatellar fat pad.

1.2 mL injection with hypertonic saline (7%) in the deltoid muscle.

Interventions

Hypertonic saline knee and shoulder injection

0.25 mL injection with hypertonic saline (7%) in the infrapatellar fat pad.

1.2 mL injection with hypertonic saline (7%) in the deltoid muscle.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy men and women aged 18-45 years
• Must have a smartphone available during the experiment

Exclusion Criteria

• Pregnancy
• Drug addiction, defined as the use of cannabis, opioids, or other drugs
• Previous or current neurologic or musculoskeletal illnesses
• Current pain
• Lack of ability to cooperate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Kristian Kjær Petersen

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristian KS Petersen

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

Aalborg University

Aalborg, North Denmark, Denmark

Countries

Denmark

Other Identifiers

N-20220063-3

Identifier Type: -

Identifier Source: org_study_id