Dextrose Prolotherapy Versus LLLT in Treatment of Obstructive Sleep Apnea
NCT ID: NCT06427161
Last Updated: 2024-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2023-04-12
2024-04-21
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group Ipatients were treated with LLLT.
patients were treated with LLLT.
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.
Group II
patients were treated with dextrose injection.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
\-
18 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Amira attia
Assistant professor of oral and maxillo-facial surgery Faculty of Dentistry, Mansoura University
Locations
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Mansoura University
Al Mansoura City, Eldakahlia, Egypt
Countries
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References
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Attia AAMM, Haggag MA, Ahmed WS, El-Saed A, Saleh MAM, Saleh AM. Dextrose prolotherapy versus low level laser therapy in the treatment of patients with obstructive sleep apnea syndrome; a randomized controlled trial. Sleep Breath. 2025 Aug 12;29(5):272. doi: 10.1007/s11325-025-03428-7.
Other Identifiers
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R.23.03.2095-2023/03/07
Identifier Type: -
Identifier Source: org_study_id
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