Using high intensity focused ultrasound to improve sleep quality in obese women with double chins
Effect of High Intensity Focused Ultrasound on Sleep Quality Measures in Obese Doubled Chin Women
NA · Cairo University · NCT06217445
This study is testing if high intensity focused ultrasound can help improve sleep quality in obese women aged 35 to 50 who have double chins.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 35 Years to 50 Years |
| Sex | Female |
| Sponsor | Cairo University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Giza) |
| Trial ID | NCT06217445 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of high intensity focused ultrasound (HIFU) on sleep quality in obese women aged 35 to 50 with double chins. The intervention involves applying HIFU, a non-invasive technique that targets tissue using focused ultrasonic waves, alongside doubled chin exercises. Participants will be assessed for changes in sleep quality measures before and after the treatment. The study seeks to determine if HIFU can provide significant improvements in sleep quality for this specific population.
Who should consider this trial
Good fit: Ideal candidates are female subjects aged 35 to 50 with a BMI between 30 and 39.9 who are clinically stable.
Not a fit: Patients with neurological conditions, acute illnesses, or contraindications for HIFU will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance sleep quality and overall well-being for obese women with double chins.
How similar studies have performed: While HIFU has shown promise in various applications, this specific approach targeting sleep quality in obese women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients that will be included in this study will meet the following criteria: 1. Female subjects with age ranged from 35 to 50 years old. 2. BMI will be 30-39.9. Class I,II BMI was classified into six groups: underweight (\<18.5 kg/m2) normal (18.5-24.9 kg/m2) pre-obesity (25-29.9 kg/m2) obesity class I (30-34.9 kg/m2) obesity class II (35-39.9 kg/m2) obesity class III (\>40 kg/m2) 3. Clinically and medically stable. 4. Able to understand the requirements of the study. 5.Thyroxin normal level( thyroid-stimulating hormone) (0.35 and 5.0milli-International unit( mIU/L) Exclusion Criteria: - The potential participants will be excluded if they meet one of the following criteria: 1. Neurological conditions (e.g., stroke history, Parkinson's disease). 2. Presence of an acute illness. 3. Renal and Hepatic diseases. 4. Patient undergoes chemotherapy. 5. Recent surgery. 6. Any contraindications for using HIFU such as:pregnancy ,metal prosthesis or implants,epilepsy,diabetes, autoimmune conditions,heart diseases including pacemaker,thrombosis . 8-BMI less than 30 and more than 39.9. 9-Age less than 35 and more than 50. 10-Male subjects.
Where this trial is running
Giza
- Faculty of Physical Therapy — Giza, Egypt (RECRUITING)
Study contacts
- Study coordinator: Nahla tharwat mousa ahmed, ASS.LEC
- Email: nahlatharwat1@cu.edu.eg
- Phone: 01096254602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: OBESITY