Dextrose Prolotherapy Versus LLLT in Treatment of Obstructive Sleep Apnea

NCT06427161 | Completed

• 1 other identifier: R.23.03.2095-2023/03/07
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea

Keywords

Dextrose; LLLT; obstructive sleep apnea

Outcome Measures

Primary Outcomes (2)

• 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.

• Polysomnography

  • All patients underwent full night attended polysomnography in the sleep laboratory of Mansoura university hospital, Chest department.

  1 week after last treatment session.

Study Arms (2)

Group Ipatients were treated with LLLT.

ACTIVE COMPARATOR

patients were treated with LLLT.

Procedure: LLLT application; Procedure: dextrose injection

Group II

ACTIVE COMPARATOR

patients were treated with dextrose injection.

Procedure: LLLT application; Procedure: dextrose injection

Interventions

LLLT application PROCEDURE

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.

Group II; Group Ipatients were treated with LLLT.

dextrose injection PROCEDURE

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; Group Ipatients were treated with LLLT.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant patients
• Active infectious disease (flu like symptoms).
• Serious co-morbidity such as chronic or decompensated liver disease, and chronic kidney disease with creatinine clearance less than 30%.
• Patients with neuromuscular disorders.
• Previous trauma to the head, and neck.
• Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction).
• Tonsil size ≥ +3.
• Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
• Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
• Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).
• History of radiation therapy to neck or upper respiratory tract
• Patients with any cardiac diseases such as heart failure, rheumatic heart diseases, coronary artery disease, and myocardial infarction (MI).
• Patients take up medications that will alter pain perception.
• History of dementia or active psychiatric disease that may impact study compliance.
• Patients who refuse the procedure.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansoura City, Eldakahlia, 35516, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40794160 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Glucose

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of oral and maxillo-facial surgery Faculty of Dentistry, Mansoura University

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 23, 2024
• Study Start: April 12, 2023
• Primary Completion: January 5, 2024
• Study Completion: April 21, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)