Obstructive Sleep ApneaNCT06427161
Dextrose Prolotherapy Versus LLLT in Treatment of Obstructive Sleep Apnea
A study testing LLLT application and dextrose injection in people with Obstructive Sleep Apnea, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- LLLT application and dextrose injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2023to 21 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients, diagnosed as having OSA after full night polysomnography. • BMI is between 28 kg/m2 and 40 kg/m2 at enrollment
Who cannot join
- 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).
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dextrose Prolotherapy Versus Low Level Laser Therapy in Treatment of Patients With Obstructive Sleep Apnea Syndrome
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
Read the 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
- Being tested
- LLLT application, dextrose injection
- Keywords
- Dextrose, LLLT, obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLLT applicationProcedure or surgery
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 injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Ipatients were treated with LLLT. | Active comparator | patients were treated with LLLT. Receives: Procedure: LLLT application; Procedure: dextrose injection |
| Group II | Active comparator | patients were treated with dextrose injection. Receives: Procedure: LLLT application; Procedure: dextrose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth sleepiness scale
No chance of dozing =0, Slight chance of dozing =1, Moderate chance of dozing =2, High chance of dozing =3
Measured: 1 week after last treatment session.
Polysomnography
- All patients underwent full night attended polysomnography in the sleep laboratory of Mansoura university hospital, Chest department.
Measured: 1 week after last treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start12 Apr 2023
- Primary completion5 Jan 2024
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira attia, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427161
- Sponsor's protocol ID
- R.23.03.2095-2023/03/07
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40794160
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextrose Prolotherapy Versus Low Level Laser Therapy in Treatment of Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT06427161
- Acronym / sponsor ID
- R.23.03.2095-2023/03/07
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Dextrose, LLLT, obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Group Ipatients were treated with LLLT. | Active comparator | Procedure: LLLT application, Procedure: dextrose injectionpatients were treated with LLLT. |
| Group II | Active comparator | Procedure: LLLT application, Procedure: dextrose injectionpatients were treated with dextrose injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients, diagnosed as having OSA after full night polysomnography. • BMI is between 28 kg/m2 and 40 kg/m2 at enrollment
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLLT applicationThe 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 or surgery | Group II, Group Ipatients were treated with LLLT. |
| dextrose injection25% 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. | Procedure or surgery | Group II, Group Ipatients were treated with LLLT. |
Primary outcome
Epworth sleepiness scale
Time frame: 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
Time frame: 1 week after last treatment session.
• All patients underwent full night attended polysomnography in the sleep laboratory of Mansoura university hospital, Chest department.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 40794160Attia 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLLT application and dextrose injection in people with Obstructive Sleep Apnea, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth sleepiness scale (time frame: 1 week after last treatment session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.