Dextrose Prolotherapy Versus LLLT in Treatment of Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: LLLT application; Procedure: dextrose injection

• Registration Number: NCT06427161
• Lead Sponsor: Mansoura University

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; 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

Study Timeline

• Study Start: 2023-04-12
• Primary Completion: 2024-01-05
• Study Completion: 2024-04-21
• Status Verified: 2024-05
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• All adult patients, diagnosed as having OSA after full night polysomnography. • BMI is between 28 kg/m2 and 40 kg/m2 at enrollment

Exclusion Criteria

1. Pregnant patients

2. Active infectious disease (flu like symptoms).

3. Serious co-morbidity such as chronic or decompensated liver disease, and chronic kidney disease with creatinine clearance less than 30%.

4. Patients with neuromuscular disorders.

5. Previous trauma to the head, and neck.

6. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction).

7. Tonsil size ≥ +3.

8. Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).

9. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).

10. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).

11. History of radiation therapy to neck or upper respiratory tract

12. Patients with any cardiac diseases such as heart failure, rheumatic heart diseases, coronary artery disease, and myocardial infarction (MI).

13. Patients take up medications that will alter pain perception.

14. History of dementia or active psychiatric disease that may impact study compliance.

15. Patients who refuse the procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	dextrose injection	patients were treated with dextrose injection.
Group Ipatients were treated with LLLT.	LLLT application	patients were treated with LLLT.
Group Ipatients were treated with LLLT.	dextrose injection	patients were treated with LLLT.
Group II	LLLT application	patients were treated with dextrose injection.

Primary Outcome Measures

Name	Time	Method
Epworth sleepiness scale	1 week after last treatment session.	No chance of dozing =0, Slight chance of dozing =1, Moderate chance of dozing =2, High chance of dozing =3
Polysomnography	1 week after last treatment session.	• All patients underwent full night attended polysomnography in the sleep laboratory of Mansoura university hospital, Chest department.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Al Mansoura City, Eldakahlia, Egypt