OBESITYNCT06217445
Effect of HIFU on Sleep Quality Measures in Obese Doubled Chin Women
A study testing high intensity focused ultrasound and Doubled chin exercises in people with OBESITY, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- OBESITY
- What is being tested?
- high intensity focused ultrasound and Doubled chin exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2024to 6 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 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All patients that will be included in this study will meet the following criteria:
- Female subjects with age ranged from 35 to 50 years old.
- 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)
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Neurological conditions (e.g., stroke history, Parkinson's disease).
- Presence of an acute illness.
- Renal and Hepatic diseases.
- Patient undergoes chemotherapy.
- Recent surgery.
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Giza, 12613
HANI ezzat obaya, PROF .ASS.DR, 01150262666, hany_obaya@yahoo.com
About this study
Official title: Effect of High Intensity Focused Ultrasound on Sleep Quality Measures in Obese Doubled Chin Women
This study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women.
Read the detailed description
PURPOSE:
This study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women.
BACKGROUND:
High-intensity focused ultrasound (HIFU) therapy is becoming more familiar in medical field because it is non-invasive technique with fewer side effects and provides promising therapeutic results. Several HIFU therapy applications have approved by many approval authorities of deferent countries since last decade.
HIFU cauterizes tissue from outside the body by focusing ultrasonic waves from a transducer with many ultrasonic sources on a single point, known as the target tumor .This modality is groundbreaking because it only causes coagulative necrosis via thermal and non-thermal energy (mainly cavitation) to the focal area, with hardly any impact on the intervening tissue outside the focal area.
Central obesity is significant predictor of metabolic syndrome and is associated with an increased risk of many medical conditions, including cardiovascular diseases (CVD), stroke , type 2 diabetes mellitus, hypertension , various types of cancer (e.g. colorectum, pancreas, endometrium, and breast) and all-cause mortality
Hypotheses of the study(Null) There is no significant effect of High Intensity Focused Ultrasound on sleep quality measures in obese doubled chin women.
Statement of the problem:
Is there any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women?
- Conditions
- OBESITY
- Being tested
- high intensity focused ultrasound, Doubled chin exercises
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity focused ultrasoundDevice
High-intensity focused ultrasound (HIFU) therapy is becoming more familiar in medical field because it is non-invasive technique with fewer side effects and provides promising therapeutic results. Several HIFU therapy applications have approved by many approval authorities of deferent countries since last decade
Doubled chin exercisesOther
- Straight jaw jut. 2-ball exercise. 3-Pucker up 4. Tongue stretch 5. Neck stretch 6-bottom jaw jut.
| Study group | Role | What they receive |
|---|---|---|
| HIFU plus exercises | Experimental | 1. A physician or technician first cleans the target area.
2. They may apply a topical anesthetic cream before starting.
3. The physician or technician then applies an ultrasound gel.
4. The HIFU device is placed against the skin.
5. Using an ultrasound viewer, the physician or technician adjusts the device to the right setting.
6. Ultrasound energy is then delivered to the target area in short pulses for roughly 30 to 90 minutes.
7. The device is removed. Receives: Device: high intensity focused ultrasound |
| doubled chin exercises | Experimental | 1. Straight jaw jut
2. Ball exercise
3. Pucker up
.
4. Tongue stretch
5. Neck stretch
6. Bottom jaw jut Receives: Other: Doubled chin exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
submental fat scale
It ranges from 0 (no localised sub-mental fat) to 4 (extreme submental convexity). The ideal patient for would be someone who is a '2' or '3' on sub-mental scale, so someone with moderate to severe sub-mental fullness
Measured: 3 months
Spirometric assessment for obesity
patients underwent spirometry tests with measurement of forced expiratory volume in first second (FEV1), forced vital capacity (FVC)and(MVV)
Measured: 3 months
Impact of Weight on Quality of Life Assessment Tools:
The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a validated, 31-item, self-report measure of obesity-specific quality of life in adults, available in multiple languages. scale structure of the IWQOL-Lite has been verified with confirmatory factor analysis, and IWQOL-Lite scores are sensitive to changes in weight. There is strong evidence for validity and reliability.
▪ In addition to a total score, there are scores on five domains:
- Physical function (11 items)
- Self-esteem (7 items)
- Sexual life (4 items)
- Public distress (5 items)
- Work (4 items) Scores range from 0 to 100, with 100 representing the best quality of life. Raw scores are no longer used for reporting
Measured: 3 months
Secondary outcomes (3)
Assessment of hormonal changes
there might also be deposits of fat around the neck, resulting in a double chin or moon face appearance. This appearance has been linked to glucose and cortisol imbalances, and diminished thyroid function. SO measure cortisol hormone.
A cortisol test often uses a sample of blood drawn at a lab. cortisol level is a blood test that measures the amount of cortisol, a steroid hormone produced by the adrenal cortex.
Normal values for a blood sample taken at 8 in the morning are 5 to 25 mcg/dL.
A higher than normal level may indicate:
Cushing disease Ectopic Cushing syndrome, in which a tumor outside the pituitary or adrenal glands makes too much ACTH Tumor of the adrenal gland,stress,acute illness
A lower than normal level may indicate:
Addison disease Suppression of normal pituitary or adrenal function by glucocorticoid medicines
Measured: 3 months
Assessment of snoring
scale from 0-5 . 0 indicate no snoring. 1 indicate rarely slight snoring depends on sleep position. 2 indicate continuous slight snoring without hypopnea or apnea. 3 indicate sometimes loud snoring without hypopnea or apnea. 4 indicate continuous loud snoring without hypopnea or apnea.5 indicate continuous loud snoring with hypopnea or apnea
Measured: 3 months
Assessment of sleep apnea:
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values for adults are categorized as:
- Normal: AHI<5
- Mild sleep apnea: 5≤AHI<15
- Moderate sleep apnea: 15≤AHI<30
- Severe sleep apnea: AHI≥30
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start6 Jan 2024
- Primary completion6 Apr 2024 (estimated)
- Study completion6 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OBESITYStudies of the same condition, open and under way.
- More trials run by Cairo 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 study is type of clinical study in which two or more groups of participants receive different interventions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Tharwat Mousa Ahmed, Cairo University
- Investigators
- HANI EZZAT OBAYA, prof ass.dr, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217445
- Sponsor's protocol ID
- HIFU treatment on obese women
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ayatollahi A, Gholami J, Saberi M, Hosseini H, Firooz A. Systematic review and meta-analysis of safety and efficacy of high-intensity focused ultrasound (HIFU) for face and neck rejuvenation. Lasers Med Sci. 2020 Jul;35(5):1007-1024. doi: 10.1007/s10103-020-02957-9. Epub 2020 Feb 5.
PubMed 32026164Zhou X, Li Y, Zhu Q, Luo J, Cao L, Quetai J, Li F, Tang MX, Wang Z. A Theragnostic HIFU Transducer and System for Inherently Registered Imaging and Therapy. IEEE Trans Biomed Eng. 2023 Dec;70(12):3413-3424. doi: 10.1109/TBME.2023.3287870. Epub 2023 Nov 21.
PubMed 37339046
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Focused Ultrasound on Sleep Quality Measures in Obese Doubled Chin Women
- ClinicalTrials.gov ID
- NCT06217445
- Acronym / sponsor ID
- HIFU treatment on obese women
- Conditions
- OBESITY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 6 Apr 2024 (estimated)
- Study completion
- 6 Apr 2024 (estimated)
- First posted
- 22 Jan 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 will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women.
Detailed description
PURPOSE:
This study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women.
BACKGROUND:
High-intensity focused ultrasound (HIFU) therapy is becoming more familiar in medical field because it is non-invasive technique with fewer side effects and provides promising therapeutic results. Several HIFU therapy applications have approved by many approval authorities of deferent countries since last decade.
HIFU cauterizes tissue from outside the body by focusing ultrasonic waves from a transducer with many ultrasonic sources on a single point, known as the target tumor .This modality is groundbreaking because it only causes coagulative necrosis via thermal and non-thermal energy (mainly cavitation) to the focal area, with hardly any impact on the intervening tissue outside the focal area.
Central obesity is significant predictor of metabolic syndrome and is associated with an increased risk of many medical conditions, including cardiovascular diseases (CVD), stroke , type 2 diabetes mellitus, hypertension , various types of cancer (e.g. colorectum, pancreas, endometrium, and breast) and all-cause mortality
Hypotheses of the study(Null) There is no significant effect of High Intensity Focused Ultrasound on sleep quality measures in obese doubled chin women.
Statement of the problem:
Is there any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel study is type of clinical study in which two or more groups of participants receive different interventions.
| Arm | Type | Receives |
|---|---|---|
| HIFU plus exercises | Experimental | Device: high intensity focused ultrasound1. A physician or technician first cleans the target area. 2. They may apply a topical anesthetic cream before starting. 3. The physician or technician then applies an ultrasound gel. 4. The HIFU device is placed against the skin. 5. Using an ultrasound viewer, the physician or technician adjusts the device to the right setting. 6. Ultrasound energy is then delivered to the target area in short pulses for roughly 30 to 90 minutes. 7. The device is removed. |
| doubled chin exercises | Experimental | Other: Doubled chin exercises1. Straight jaw jut 2. Ball exercise 3. Pucker up . 4. Tongue stretch 5. Neck stretch 6. Bottom jaw jut |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All patients that will be included in this study will meet the following criteria:
- 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)
Key exclusion criteria (8 listed)
- The potential participants will be excluded if they meet one of the following criteria:
- Neurological conditions (e.g., stroke history, Parkinson's disease).
- Presence of an acute illness.
- Renal and Hepatic diseases.
- Patient undergoes chemotherapy.
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 |
|---|---|---|
| high intensity focused ultrasoundHigh-intensity focused ultrasound (HIFU) therapy is becoming more familiar in medical field because it is non-invasive technique with fewer side effects and provides promising therapeutic results. Several HIFU therapy applications have approved by many approval authorities of deferent countries since last decade | Device | HIFU plus exercises |
| Doubled chin exercises1. Straight jaw jut. 2-ball exercise. 3-Pucker up 4. Tongue stretch 5. Neck stretch 6-bottom jaw jut. | Other | doubled chin exercises |
Primary outcome
submental fat scale
Time frame: 3 months
It ranges from 0 (no localised sub-mental fat) to 4 (extreme submental convexity). The ideal patient for would be someone who is a '2' or '3' on sub-mental scale, so someone with moderate to severe sub-mental fullness
Spirometric assessment for obesity
Time frame: 3 months
patients underwent spirometry tests with measurement of forced expiratory volume in first second (FEV1), forced vital capacity (FVC)and(MVV)
Impact of Weight on Quality of Life Assessment Tools:
Time frame: 3 months
The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a validated, 31-item, self-report measure of obesity-specific quality of life in adults, available in multiple languages. scale structure of the IWQOL-Lite has been verified with confirmatory factor analysis, and IWQOL-Lite scores are sensitive to changes in weight. There is strong evidence for validity and reliability. ▪ In addition to a total score, there are scores on five domains: * Physical function (11 items) * Self-esteem (7 items) * Sexual life (4 items) * Public distress (5 items) * Work (4 items) Scores range from 0 to 100, with 100 representing the best quality of life. Raw scores are no longer used for reporting
3 secondary outcomes
Assessment of hormonal changes
Time frame: 3 months
Assessment of snoring
Time frame: 3 months
Assessment of sleep apnea:
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Background: PubMed 32026164Ayatollahi A, Gholami J, Saberi M, Hosseini H, Firooz A. Systematic review and meta-analysis of safety and efficacy of high-intensity focused ultrasound (HIFU) for face and neck rejuvenation. Lasers Med Sci. 2020 Jul;35(5):1007-1024. doi: 10.1007/s10103-020-02957-9. Epub 2020 Feb 5.
- Background: PubMed 37339046Zhou X, Li Y, Zhu Q, Luo J, Cao L, Quetai J, Li F, Tang MX, Wang Z. A Theragnostic HIFU Transducer and System for Inherently Registered Imaging and Therapy. IEEE Trans Biomed Eng. 2023 Dec;70(12):3413-3424. doi: 10.1109/TBME.2023.3287870. Epub 2023 Nov 21.
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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.
HANI EZZAT OBAYA, prof ass.dr study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity focused ultrasound and Doubled chin exercises in people with OBESITY, run by Cairo 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nahla tharwat mousa ahmed, ASS.LEC (01096254602, nahlatharwat1@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
submental fat scale (time frame: 3 months). The study lists 3 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 NCT06217445, which also lists 2 linked publications.
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 22 Jan 2024.