Dextrose Prolotherapy Versus LLLT in Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06427161
• Other study ID #: R.23.03.2095-2023/03/07
• Status: Completed
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: April 21, 2024

Study information

• Verified date: May 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 21, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Mansoura University	Al Mansoura City	Eldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

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