Sleep Apnea, ObstructiveNCT05133011
Force Sensing Resistor for Obstructive Sleep Apnea Patients After Tongue Base Reduction Surgery
A study testing Tongue base reduction surgery in people with Sleep Apnea, Obstructive, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Obstructive sleep apnea syndrome (OSA) is a sleep-related breathing disorder defined by repetitive episodes of apnea and hypopnea. These traits include anatomical (narrow/crowded/collapsible upper airway) and nonanatomical (waking up too easily during airway narrowing [a low respiratory arousal threshold], ineffective… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Tongue base reduction surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 22 Mar 2023
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of mild to severe OSA in the past year
- Agree to receive Transoral Robotic Surgery (TORS)
- Age between 20-65 years old.
Who cannot join
- Body Mass Index ≧ 32
- Drug abuse within one year
- Pregnant
- Severe obstructive or restrictive lung disease
- A history of malignancy or infection of the head and neck region and laryngeal trauma
- Craniofacial malformation
Show all 13Show fewer
- Stroke
- Neuromuscular disease
- Heart failure
- Coronary artery disease
- Ongoing or uncontrolled chronic diseases
- Combine central or mixed types sleep apnea syndrome
- Other non-breath related sleep disorder.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Cheng Kung University Hospital
Tainan, Please Select, 412
About this study
Official title: Efficacy of Force Sensing Resistor Assisted Physical Therapy Program for Obstructive Sleep Apnea With Low-responsiveness of Oropharyngeal Muscle Patients After Tongue Base Reduction Surgery：Establishment of Precision Medicine
Obstructive sleep apnea syndrome (OSA) is a sleep-related breathing disorder defined by repetitive episodes of apnea and hypopnea. These traits include anatomical (narrow/crowded/collapsible upper airway) and nonanatomical (waking up too easily during airway narrowing [a low respiratory arousal threshold], ineffective or reduced pharyngeal dilator muscle activity during sleep, and unstable ventilatory control [high loop gain]) components. Oropharyngeal training reduces the snoring times, Apnea-hypopnea Index (AHI) and daytime sleepiness. There is lack of good evaluating tools to distinguish different phenotypes of OSA and the efficacy of combined therapy. The purposes of our study are (1) to evaluate OSA patient by using Polysomonogrphy (PSG), force sensing resistor (FRS), Drug induce sleep endoscopy (DISE) and CT and muscle strength testing, (2) to know the exercise times by using FSR and (3) the efficacy of exercise in different groups.
Read the detailed description
Subjects who are newly diagnosed with mild to severe OSA (AHI >5/h), and the physician will explain the treatment programs to every subject. By the result of muscle strength testing, the subjects will be classified as low muscle strength and normal groups. The myofunctional therapy program will begin at 6 week after surgery, and subjects will undergo 12 weeks of the home-based oropharyngeal myofunctional therapeutic training. During the training intervention period, subjects will be interviewed one time per week for adjusting the treatment intensity.
Expected results：The hypothesis of this study is the efficacy of exercise would be less in the low muscle strength OSA patient than normal.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Tongue base reduction surgery
- 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.
Tongue base reduction surgeryProcedure or surgery
Tongue base reduction surgery which remove the extra soft tissue of the base of the tongue and soft palate in this study
| Study group | Role | What they receive |
|---|---|---|
| Low muscle strength | Experimental | The participants underwent before tongue base reduction surgery used Iowa Oral Performance Instrument (IOPI) system test upper tongue muscle strength were the last 5% Receives: Procedure: Tongue base reduction surgery |
| Normal groups | Experimental | The participants underwent before tongue base reduction surgery used Iowa Oral Performance Instrument (IOPI) system test upper tongue muscle strength were greater than 5% Receives: Procedure: Tongue base reduction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Apnea and Hypopnea index (AHI) at post op 6 weeks and 18 weeks
Polysomnography included electroencephalographic, electro-oculographic, thoracic and abdominal respiratory inductance plethysmography and body position sensor to confirm the sleeping stage in one-night observation. Above measurements will be aggregated to arrive AHI.
Measured: through study completion, an average of 18 weeks
Change from Baseline Volume from hard palate to the base of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Volume from hard palate to the base of epiglottis was measured.
Measured: through study completion, an average of 18 weeks
Change from Baseline Cross section area on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Cross section area on the tip of epiglottis was measured.
Measured: through study completion, an average of 18 weeks
Change from Baseline Anterior to posterior distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured.
Measured: through study completion, an average of 18 weeks
Change from Baseline Lateral distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured.
Measured: through study completion, an average of 18 weeks
Change from Baseline Drug-induced sleep endoscopy (DISE) at post op 6 weeks and 18 weeks
DISE was carried out by an experienced ENT surgeon in a semi-dark and quiet operating room with the patient supine lying on a hospital bed. Artificial sleep was induced by intravenous injection of propofol and midazolam (bolus injection of 1.5 mg) through a target-controlled infusion system (1.5 to 3.0 lg/mL), intending to the transition to unconsciousness with beginning of snoring and with the examiner evaluating decreased muscle reflexes of the eyelid. The severity of collapse in the upper airway was assessed by the surgeon.
Measured: through study completion, an average of 18 weeks
Change from Baseline Muscle Strength of Jaw at post op 6 weeks and 18 weeks
Muscle strength of jaw was measured with a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA) mounted on an adapted ophthalmic examination frame, to avoid alterations in chin and head position and to ensure consistent compression.
Measured: through study completion, an average of 18 weeks
Change from Baseline Muscle strength of tongue at post op 6 weeks and 18 weeks
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Measured: through study completion, an average of 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Hsia Hung, PhD, Principal investigator, Department of physical therapy, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133011
- Sponsor's protocol ID
- B-BR-109-058
- Status last verified
- Nov 2021
- First submitted
- 14 Nov 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Force Sensing Resistor Assisted Physical Therapy Program for Obstructive Sleep Apnea With Low-responsiveness of Oropharyngeal Muscle Patients After Tongue Base Reduction Surgery：Establishment of Precision Medicine
- ClinicalTrials.gov ID
- NCT05133011
- Acronym / sponsor ID
- B-BR-109-058
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 24 Nov 2021 (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.
Obstructive sleep apnea syndrome (OSA) is a sleep-related breathing disorder defined by repetitive episodes of apnea and hypopnea. These traits include anatomical (narrow/crowded/collapsible upper airway) and nonanatomical (waking up too easily during airway narrowing [a low respiratory arousal threshold], ineffective or reduced pharyngeal dilator muscle activity during sleep, and unstable ventilatory control [high loop gain]) components. Oropharyngeal training reduces the snoring times, Apnea-hypopnea Index (AHI) and daytime sleepiness. There is lack of good evaluating tools to distinguish different phenotypes of OSA and the efficacy of combined therapy. The purposes of our study are (1) to evaluate OSA patient by using Polysomonogrphy (PSG), force sensing resistor (FRS), Drug induce sleep endoscopy (DISE) and CT and muscle strength testing, (2) to know the exercise times by using FSR and (3) the efficacy of exercise in different groups.
Detailed description
Subjects who are newly diagnosed with mild to severe OSA (AHI >5/h), and the physician will explain the treatment programs to every subject. By the result of muscle strength testing, the subjects will be classified as low muscle strength and normal groups. The myofunctional therapy program will begin at 6 week after surgery, and subjects will undergo 12 weeks of the home-based oropharyngeal myofunctional therapeutic training. During the training intervention period, subjects will be interviewed one time per week for adjusting the treatment intensity.
Expected results：The hypothesis of this study is the efficacy of exercise would be less in the low muscle strength OSA patient than normal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low muscle strength | Experimental | Procedure: Tongue base reduction surgeryThe participants underwent before tongue base reduction surgery used Iowa Oral Performance Instrument (IOPI) system test upper tongue muscle strength were the last 5% |
| Normal groups | Experimental | Procedure: Tongue base reduction surgeryThe participants underwent before tongue base reduction surgery used Iowa Oral Performance Instrument (IOPI) system test upper tongue muscle strength were greater than 5% |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of mild to severe OSA in the past year
- Agree to receive Transoral Robotic Surgery (TORS)
- Age between 20-65 years old.
Key exclusion criteria (13 listed)
- Body Mass Index ≧ 32
- Drug abuse within one year
- Pregnant
- Severe obstructive or restrictive lung disease
- A history of malignancy or infection of the head and neck region and laryngeal trauma
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 |
|---|---|---|
| Tongue base reduction surgeryTongue base reduction surgery which remove the extra soft tissue of the base of the tongue and soft palate in this study | Procedure or surgery | Low muscle strength, Normal groups |
Primary outcome
Change from Baseline Apnea and Hypopnea index (AHI) at post op 6 weeks and 18 weeks
Time frame: through study completion, an average of 18 weeks
Polysomnography included electroencephalographic, electro-oculographic, thoracic and abdominal respiratory inductance plethysmography and body position sensor to confirm the sleeping stage in one-night observation. Above measurements will be aggregated to arrive AHI.
Change from Baseline Volume from hard palate to the base of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
Time frame: through study completion, an average of 18 weeks
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Volume from hard palate to the base of epiglottis was measured.
Change from Baseline Cross section area on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
Time frame: through study completion, an average of 18 weeks
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Cross section area on the tip of epiglottis was measured.
Change from Baseline Anterior to posterior distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
Time frame: through study completion, an average of 18 weeks
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured.
Change from Baseline Lateral distance on the tip of epiglottis in computer tomography (CT) at post op 6 weeks and 18 weeks
Time frame: through study completion, an average of 18 weeks
All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured.
Change from Baseline Drug-induced sleep endoscopy (DISE) at post op 6 weeks and 18 weeks
Time frame: through study completion, an average of 18 weeks
DISE was carried out by an experienced ENT surgeon in a semi-dark and quiet operating room with the patient supine lying on a hospital bed. Artificial sleep was induced by intravenous injection of propofol and midazolam (bolus injection of 1.5 mg) through a target-controlled infusion system (1.5 to 3.0 lg/mL), intending to the transition to unconsciousness with beginning of snoring and with the examiner evaluating decreased muscle reflexes of the eyelid. The severity of collapse in the upper airway was assessed by the surgeon.
Change from Baseline Muscle Strength of Jaw at post op 6 weeks and 18 weeks
Time frame: through study completion, an average of 18 weeks
Muscle strength of jaw was measured with a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA) mounted on an adapted ophthalmic examination frame, to avoid alterations in chin and head position and to ensure consistent compression.
Change from Baseline Muscle strength of tongue at post op 6 weeks and 18 weeks
Time frame: through study completion, an average of 18 weeks
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
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 Mar 2023.
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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.
Ching-Hsia Hung, PhD principal investigator
Department of physical therapy, National Cheng Kung 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 Tongue base reduction surgery in people with Sleep Apnea, Obstructive, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 3 inclusion and 13 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 Mar 2023. 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 Taiwan. 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?
Change from Baseline Apnea and Hypopnea index (AHI) at post op 6 weeks and 18 weeks (time frame: through study completion, an average of 18 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.