NCT06427161

Dextrose Prolotherapy Versus LLLT in Treatment of Obstructive Sleep Apnea

Dextrose Prolotherapy Versus Low Level Laser Therapy in Treatment of Patients With Obstructive Sleep Apnea Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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; 1/2 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

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
PROCEDURE	LLLT application	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 was used, and the radiant energy was 2J (250uw X 8 sec) for each point. Total energy was 16J (2J X 8 points) for each session.
PROCEDURE	dextrose injection	25% dextrose was injected in the same 8 points; 1/2 ml for each point, total 4ml for each session. The injection was done weekly, up to 4 sessions.

Timeline

• Start date: 2023-04-12
• Primary completion: 2024-01-05
• Completion: 2024-04-21
• First posted: 2024-05-23
• Last updated: 2024-05-23

Locations

1 site across 1 country: Egypt