Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427161
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-05-16
Brief Title:
Dextrose Prolotherapy Versus LLLT in Treatment of Obstructive Sleep Apnea
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Dextrose Prolotherapy Versus Low Level Laser Therapy in Treatment of Patients With Obstructive Sleep Apnea Syndrome
Status:
COMPLETED
Status Verified Date:
2024-05
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 study was conducted on 26 patients with obstructive sleep apnea The patients were divided randomly and equally into two equal groups In group I the patients were treated with LLLT while in group II the patients were treated with dextrose injection The patients were evaluated by Medical history utilizing sleep unit medical sheet physical examination including anthropometric measures epworth sleepiness scale and Berlin questioner and Polysomnography
Detailed Description:
This study was conducted on 26 patients with OSA attending to sleep disorders breathing Unit Chest Department and oral and maxillofacial department at Mansoura University confirmed by polysomnography The study was implemented over 2 months The patients were divided randomly and equally into two therapy groups each compromise 13 patients
Group I patients will be treated with LLLT Group II patients will be treated with dextrose injection
Interventions
The LLLT group received the laser application at 8 points once a week over a 2-month period totaling 8 sessions Each point was stimulated for 8 seconds in the soft palate uvula pharyngeal walls palatine tonsils and on the tongue base LLLT protocol Diode laser 810nm in continuous contact mode will be used and the radiant energy will be 2J 250uw X 8 sec for each point Total energy will be 16J 2J X 8 points for each session
Dextrose injection Protocol 25 dextrose was injected in the same 8 points 12 ml for each point total 4ml for each session The injection was done weekly up to 4 sessions
Clinical assessment
Medical history utilizing sleep unit medical sheet will be taken from all patients Attention was given to Night symptoms such as snoring choking witnessed apnea bad dreams and nocturia and daytime symptoms morning headache excessive daytime sleepiness
Physical examination including Anthropometric measures Height weight body-mass index BMI teeth imprint abdominal circumference Epworth sleepiness scale Arabic version and Berlin questioner Arabic version
Polysomnography
Group I patients will be treated with LLLT Group II patients will be treated with dextrose injection
Interventions
The LLLT group received the laser application at 8 points once a week over a 2-month period totaling 8 sessions Each point was stimulated for 8 seconds in the soft palate uvula pharyngeal walls palatine tonsils and on the tongue base LLLT protocol Diode laser 810nm in continuous contact mode will be used and the radiant energy will be 2J 250uw X 8 sec for each point Total energy will be 16J 2J X 8 points for each session
Dextrose injection Protocol 25 dextrose was injected in the same 8 points 12 ml for each point total 4ml for each session The injection was done weekly up to 4 sessions
Clinical assessment
Medical history utilizing sleep unit medical sheet will be taken from all patients Attention was given to Night symptoms such as snoring choking witnessed apnea bad dreams and nocturia and daytime symptoms morning headache excessive daytime sleepiness
Physical examination including Anthropometric measures Height weight body-mass index BMI teeth imprint abdominal circumference Epworth sleepiness scale Arabic version and Berlin questioner Arabic version
Polysomnography
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