Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336109
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-22
Brief Title:
Fragmented Sleep Pain and Biomechanics
Sponsor:
Aalborg University
Organization:
Aalborg University
Study Overview
Official Title:
The Impacts of Fragmented Sleep on Biomechanics and Pain of the Shoulder and Knee
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 0000 0230 and 0500
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
The sleep fragmentation will involve three forced awakenings per night for three consecutive nights between sessions These awakenings will be planned at 0000 0230 and 0500
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None