- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07669870
LOW LEVEL LASER THERAPY VS EXERCISES FOR SNORING IN SLEEP APNEA 'S PATIENTS
THE EFEECT OF USING LOW LEVEL LASER THERAPY VS EXERCISES IN TREATMENT OF SNORING IN SLEEP APNEA 'S PATIENTS
the purpose of this study is to evaluate and compare the effectiveness of using low level laser therapy versus oropharyngeal exercises in the treatment of snoring in patient diagnosed with obstructive sleep apnea.
the study aims to determine which intervention provide better clinical outcome in reducing snoring severity and improve sleep quality
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
patients participating in this study were randomly allocated into parallel group to evaluate the therapeutic effects on snoring . one group received low level laser therapy targeting soft palate while second group received oropharyngeal and tongue exercises to strengthen upper air way muscles the treatment outcome were evaluated before and after the intervention period . the primary clinical assessment for snoring risk and severity was conducted using berlin questionnaire .
statistical analysis was performed to compare the pre and post treatment result between the groups to identify the most effective non invasive treatment modality for snoring in sleep apnea patients
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Faculty of Physcial Therapy Cairo Unvirsity
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion criteria :
Patient are clinically and medically stable 2-Patients are able to understand and follow the instruction 3-Patient 's age range from 40 to 55 years old 4-Patient are male and females 5-Patient have snoring due to diagnostic mild sleep apnea disorder 6- BMI of patients ranging from (30 - 34.9) Obesity Class I and obesity class 2 ( 35-39)
Exculsioncriteria :
- In stability of patient 's medical condition 3-In ability to comprehered and follow instruction as in dementia or speech proplems such as dysphasia 4-Patients with cognitive disorders 5-Patients with musculoskeletal and neurological problems 6- patients with diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: laser therapy group
patients in this group received low level laser therapy targeting soft palate and surrounding upper airway tissues
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laser applications to the oral mucosa and soft palate tissue
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|
Experimental: orophrgeal exercises
patient in this group performed oropharyngeal exercises and tongue exercises to strengthen upper air way
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structured myofunctional and tongue strengthening exercises for snoring reduction
|
|
No Intervention: control group
patient in this group didn't receive any active exercises or laser they receive only advices
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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snoring severity and risk using the berlin questionnaire
Time Frame: 6 weeks
|
the Berline questionnaire is used to assess the risk and severity and obstructive sleep apnea .it
consist of 3 categories addressing the severity of snoring, day time sleepiness, and history of high blood pressure or obesity changes in the questionnaire scores will be evaluated to compare the clinical outcome between the groups
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Apnea
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Apnea Syndromes
- Respiratory Sounds
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Sleep Apnea, Obstructive
- Snoring
- Therapeutics
- Laser Therapy
- Phototherapy
- Low-Level Light Therapy
Other Study ID Numbers
- P.T.REC/012/006337
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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