Sleep Apnea, ObstructiveNCT04876482
Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery
A study testing transoral robotic surgery, oral appliance and using continuous positive airway pressure in people with Sleep Apnea, Obstructive, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Background: Obstructive Sleep Apnea Syndrome (OSA) is a kind of sleep disorder. The symptoms are intermittent, partial or complete upper airway collapse, seriously impacting oxygen saturation and oxidative stress. Some patients choose to do upper airway surgeries, but the success rate is only 60-70%. 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?
- transoral robotic surgery, oral appliance and using continuous positive airway pressure
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age between 20-65 years old.
Who cannot join
- A history of malignancy or infection of the head and neck region and laryngeal trauma
- Craniofacial malformation
- Stroke
- Neuromuscular disease
- Heart failure
- Coronary artery disease.
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 Oropharyngeal Myofunctional Therapeutic Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery
Background: Obstructive Sleep Apnea Syndrome (OSA) is a kind of sleep disorder. The symptoms are intermittent, partial or complete upper airway collapse, seriously impacting oxygen saturation and oxidative stress. Some patients choose to do upper airway surgeries, but the success rate is only 60-70%. The symptoms might relapse because of aging and gaining weights. The purpose of our study is to compare the effect of transoral robotic surgery (TORS) and oropharyngeal rehabilitation (OPR) on patients after TORS. Methods: Participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index >5/h), and the physician will explain the treatment programs to every subject in clinic. Expected results: The hypothesis of this study is the success rate of surgery will be enhance by increasing tongue and jaw-opening muscle strength after OPR. The biomarkers of cardiovascular disease may decrease and both the collapse of upper airway and sleep quality may be improved after TORS and OPR.
Read the detailed description
The participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index >5/h), and the physician will explain the treatment programs to every subject. By their willingness to choose the therapeutic method, the participants who select the surgery interventions will be assign to TORS or TORS+OPR group. The matched controls as well as age-, sex-, and body mass index-matched OSA participants will be selected from the patients who are waiting for oral appliance, losing weight and using continuous positive airway pressure. Before surgery, 6 week and 18 week after surgery, the investiagters will compare the polysomnography data, questionnaires of sleep quality, drug-induced sleep endoscopy and computed tomography as primary outcomes. The investigators will also compare the tongue and jaw-opening muscle strength and biomarkers of oxidative stress, anti-oxidative stress, inflammatory cytokines and matrix metalloproteinases 9 as secondary outcomes. The OPR would begin at 6 week after surgery, and participants will undergo three months of the home-based oropharyngeal myofunctional therapeutic training. During the training intervention period, participants will be interviewed one time per week for adjusting the treatment intensity.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- transoral robotic surgery, oral appliance, using continuous positive airway pressure, losing weights, oropharyngeal rehabilitation
- 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.
transoral robotic surgeryProcedure or surgery
transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
oral applianceDevice
It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
using continuous positive airway pressureDevice
Also called CPAP
The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
losing weightsBehavioural
The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
oropharyngeal rehabilitationCombination product
Also called OPR
OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group. Receives: Device: oral appliance; Device: using continuous positive airway pressure; Behavioral: losing weights |
| Transoral robotic surgery (TORS) | Experimental | The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate. Receives: Procedure: transoral robotic surgery |
| TORS+OPR | Experimental | The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes. Receives: Procedure: transoral robotic surgery; Combination Product: oropharyngeal rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
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.
Unabbreviated scale title:Apnea and Hypopnea index The minimum value:0 The maximum values: none Higher scores mean a worse outcome.
Measured: through study completion, an average of 6 months
Computer Tomography (CT)_Volume
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 6 months
Computer Tomography (CT)_minimal Area
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 6 months
Computer Tomography (CT)_AP Distance
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 6 months
Computer Tomography (CT)_Lateral Distance
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. Lateral distance on the tip of epiglottis was measured.
Measured: through study completion, an average of 6 months
Drug-induced Sleep Endoscopy (DISE)
All patients underwent DISE in a supine position. The possible outcomes were unilevel collapse at the velum, oropharynx, tongue base, or epiglottis and multilevel collapse at any of these locations. The velum is the part of the upper airway at the level of the soft palate and uvula; the oropharynx is the pharyngeal portion at the level of the tonsils, above the tongue base. The tongue base was considered the retroglossal area; epiglottis was considered the pharyngeal region below the tongue base. The degree of obstruciton was diagnosed by an ear nose throat surgeon. The degree of obstruction ranged from 0 to 2. 0: no obstruction (<50%); 1: partial obstruction (50-75%); 2: complete obstruction (>75%).
Measured: through study completion, an average of 6 months
Jaw Opening Muscle Strength
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 6 months
Tongue Protrusion Muscle Strength
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 6 months
Tongue Elevation Muscle Strength
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 6 months
Tongue Depression Muscle Strength
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 6 months
Tongue Lateralization Muscle Strength
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 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876482
- Sponsor's protocol ID
- NCKUH-10902002
- Status last verified
- Sep 2021
- First submitted
- 3 Feb 2021
- Last updated
- 21 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oropharyngeal Myofunctional Therapeutic Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery
- ClinicalTrials.gov ID
- NCT04876482
- Acronym / sponsor ID
- NCKUH-10902002
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 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
- 31 Dec 2022 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Posted 21 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Obstructive Sleep Apnea Syndrome (OSA) is a kind of sleep disorder. The symptoms are intermittent, partial or complete upper airway collapse, seriously impacting oxygen saturation and oxidative stress. Some patients choose to do upper airway surgeries, but the success rate is only 60-70%. The symptoms might relapse because of aging and gaining weights. The purpose of our study is to compare the effect of transoral robotic surgery (TORS) and oropharyngeal rehabilitation (OPR) on patients after TORS. Methods: Participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index >5/h), and the physician will explain the treatment programs to every subject in clinic. Expected results: The hypothesis of this study is the success rate of surgery will be enhance by increasing tongue and jaw-opening muscle strength after OPR. The biomarkers of cardiovascular disease may decrease and both the collapse of upper airway and sleep quality may be improved after TORS and OPR.
Detailed description
The participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index >5/h), and the physician will explain the treatment programs to every subject. By their willingness to choose the therapeutic method, the participants who select the surgery interventions will be assign to TORS or TORS+OPR group. The matched controls as well as age-, sex-, and body mass index-matched OSA participants will be selected from the patients who are waiting for oral appliance, losing weight and using continuous positive airway pressure. Before surgery, 6 week and 18 week after surgery, the investiagters will compare the polysomnography data, questionnaires of sleep quality, drug-induced sleep endoscopy and computed tomography as primary outcomes. The investigators will also compare the tongue and jaw-opening muscle strength and biomarkers of oxidative stress, anti-oxidative stress, inflammatory cytokines and matrix metalloproteinases 9 as secondary outcomes. The OPR would begin at 6 week after surgery, and participants will undergo three months of the home-based oropharyngeal myofunctional therapeutic training. During the training intervention period, participants will be interviewed one time per week for adjusting the treatment intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: oral appliance, Device: using continuous positive airway pressure, Behavioral: losing weightsWithout the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group. |
| Transoral robotic surgery (TORS) | Experimental | Procedure: transoral robotic surgeryThe participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate. |
| TORS+OPR | Experimental | Procedure: transoral robotic surgery, Combination Product: oropharyngeal rehabilitationThe participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of mild to severe OSA in the past year
- Age between 20-65 years old.
Key exclusion criteria (6 listed)
- A history of malignancy or infection of the head and neck region and laryngeal trauma
- Craniofacial malformation
- Stroke
- Neuromuscular disease
- Heart failure
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 |
|---|---|---|
| transoral robotic surgerytransoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study | Procedure or surgery | TORS+OPR, Transoral robotic surgery (TORS) |
| oral applianceIt is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw. | Device | Control |
| using continuous positive airway pressureAlso: CPAPThe participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing. | Device | Control |
| losing weightsThe participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries. | Behavioural | Control |
| oropharyngeal rehabilitationAlso: OPROPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist. | Combination product | TORS+OPR |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: through study completion, an average of 6 months
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. Unabbreviated scale title:Apnea and Hypopnea index The minimum value:0 The maximum values: none Higher scores mean a worse outcome.
Computer Tomography (CT)_Volume
Time frame: through study completion, an average of 6 months
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.
Computer Tomography (CT)_minimal Area
Time frame: through study completion, an average of 6 months
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.
Computer Tomography (CT)_AP Distance
Time frame: through study completion, an average of 6 months
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.
Computer Tomography (CT)_Lateral Distance
Time frame: through study completion, an average of 6 months
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. Lateral distance on the tip of epiglottis was measured.
Drug-induced Sleep Endoscopy (DISE)
Time frame: through study completion, an average of 6 months
All patients underwent DISE in a supine position. The possible outcomes were unilevel collapse at the velum, oropharynx, tongue base, or epiglottis and multilevel collapse at any of these locations. The velum is the part of the upper airway at the level of the soft palate and uvula; the oropharynx is the pharyngeal portion at the level of the tonsils, above the tongue base. The tongue base was considered the retroglossal area; epiglottis was considered the pharyngeal region below the tongue base. The degree of obstruciton was diagnosed by an ear nose throat surgeon. The degree of obstruction ranged from 0 to 2. 0: no obstruction (<50%); 1: partial obstruction (50-75%); 2: complete obstruction (>75%).
Jaw Opening Muscle Strength
Time frame: through study completion, an average of 6 months
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.
Tongue Protrusion Muscle Strength
Time frame: through study completion, an average of 6 months
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Tongue Elevation Muscle Strength
Time frame: through study completion, an average of 6 months
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Tongue Depression Muscle Strength
Time frame: through study completion, an average of 6 months
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Tongue Lateralization Muscle Strength
Time frame: through study completion, an average of 6 months
The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 transoral robotic surgery, oral appliance and using continuous positive airway pressure 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 2 inclusion and 6 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 21 Oct 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 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Apnea Hypopnea Index (AHI) (time frame: through study completion, an average of 6 months). The study lists 11 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 21 Oct 2024.