Obstructive Sleep ApneaNCT06115018
The Efficacy and Maintain Effect of OPR on OSA Patients After Palatal Surgery
A study testing Palatal surgery, Oropharyngeal rehabilitation and Palatal surgery combined oropharyngeal rehabilitation in people with Obstructive Sleep Apnea, run by Yi-Ju, Lai at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate the maintain effect of palatal surgery and oropharyngeal rehabilitation (OPR) by using the severity of obstructive sleep apnea (OSA), tongue muscle strength and the space of the upper airway in patients with OSA.The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Palatal surgery, Oropharyngeal rehabilitation and Palatal surgery combined oropharyngeal rehabilitation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to severe obstructive sleep apnea patients
Who cannot join
- Chronic rhinosinusitis with nasal polyps
- Adenoidal hypertrophy
- Bilateral tonsile hypertrophy
- Morbid Obesity
- Drug or alcohol abuse in one year
- Pregnancy
Show all 10Show fewer
- Severe lung disease
- Heart disease with high risk of exercise
- Neuromuscular disease that can't follow the exercise program
- Central or mixed sleep apnea
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Yi-Ju Lai, PhD, +886-6-2353535 ext. 4063, 11208035@gs.ncku.edu.tw
About this study
Official title: The Efficacy and Maintain Effect of Oropharyngeal Rehabilitation on Obstructive Sleep Apnea Patients After Palatal Surgery
The goal of this clinical trial is to evaluate the maintain effect of palatal surgery and oropharyngeal rehabilitation (OPR) by using the severity of obstructive sleep apnea (OSA), tongue muscle strength and the space of the upper airway in patients with OSA.The main questions it aims to answer are:
- Will the severity of OSA, tongue muscle strength and the space of upper airway improve more in the palatal surgery combined OPR group than the other two groups?
- Will The maintain effect of tongue muscle strength and the space of upper airway be better in the palatal surgery combined OPR group? Participants will be divided into 3 groups including palatal surgery combined OPR group, palatal surgery group and OPR group by the doctor's advice and their willingness.The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months.
Read the detailed description
Background: The pathophysiology of obstructive sleep apnea (OSA) includes anatomical and non-anatomical factors. The patients who are suitable for sleep surgery may have the non-anatomical factors at the same time. Oropharyngeal rehabilitation (OPR) for the extrinsic and intrinsic muscles of the tongue might mitigate sleep apnea by preventing airway collapse and reducing the volume of the tongue base. In addition, previous studies also suggested that increasing the tension of the tongue extrinsic/intrinsic muscles may decrease the collapsibility of the upper airway and further prevent airway collapse during sleep. Although palatal surgery and OPR both can improve the severity of OSA, there is lack of literatures about the maintain effect of palatal surgery combined OPR. The aim of this study is to evaluate the maintain effect by using the severity of OSA, tongue muscle strength and the space of the upper airway. Our team have developed force sensing resistor to record the times and frequency of OPR at home from 2022. However, the investigators have to use SD card to record data in the present version. The investigators will optimize the force sensing resistor to upload data to Google Drive by using wifi. In this way, the investigators will know the daily training situation and give feedback to participants immediately by using LINE.
Methods：Seventy-five adult OSA patients will be recruited for this study. Participants will be divided into 3 groups including palatal surgery combined OPR group, palatal surgery group and OPR group by the doctor's advice and their willingness. In the palatal surgery combined OPR group, the participants will receive the palatal surgery and 3-month OPR. In the palatal surgery group and OPR group, the participants will receive palatal surgery or 3-month OPR, respectively. The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress. To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment.
Expected outcomes：
- The severity of OSA, tongue muscle strength and the space of upper airway will improve more in the palatal surgery combined OPR group than the other two groups.
- The maintain effect of tongue muscle strength and the space of upper airway is better in the palatal surgery combined OPR group.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Palatal surgery, Oropharyngeal rehabilitation, Palatal surgery combined oropharyngeal rehabilitation
- Keywords
- Obstructive sleep apnea, Oropharyngeal rehabilitation, Computed tomography, Tongue muscle strength, Maintain effect
- 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.
Palatal surgeryProcedure or surgery
Palate surgery has evolved from the ablative partial palate resections, which favored the removal of the soft tissue that obstructed the upper airway (UA), to more recent innovative reconstructive procedures that not only address the level of palatal obstruction, but the type of palatal or lateral pharyngeal wall collapse.
Oropharyngeal rehabilitationBehavioural
Oropharyngeal rehabilitation (OPR) focus on the upper airway muscle including tongue muscle, palatal muscles and paryngeal muscles. The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress.
Palatal surgery combined oropharyngeal rehabilitationCombination product
Participants will receive palatal surgery and post-surgery oropharyngeal rehabilitation (OPR). The palatal surgery and OPR describe as above.
| Study group | Role | What they receive |
|---|---|---|
| Palatal surgery group | Active comparator | In the palatal surgery group, the participants will receive palatal surgery.To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment. Receives: Procedure: Palatal surgery |
| Oropharyngeal rehabilitation group | Active comparator | In the oropharyngeal rehabilitation (OPR) group, the participants will receive 12-week OPR. The OPR for the OPR group included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress. To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment. Receives: Behavioral: Oropharyngeal rehabilitation |
| Palatal surgery combined OPR group | Experimental | In the palatal surgery combined OPR group, the participants will receive palatal surgery, then 12-week OPR. The program of OPR for this group is as the same of OPR group. Receives: Combination Product: Palatal surgery combined oropharyngeal rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography (PSG)
PSG will include electroencephalography, electrooculography, electromyography, thoracic and abdominal respiratory inductance plethysmography, body position sensor-modified lead II electrocardiography, oronasal thermistor, nasal cannula pressure transducer, finger pulse oximetry. The detail descriptions of each measurement are in secondary outcome measure.
From the abouve measurements, OSA severity, defined using AHI, will be diagnosed by sleep medicine specialists in the ear, nose, and throat (ENT) department. AHI denotes the number of instances of apnea and hypopnea per hour during sleep. Apnea was defined as a >90% decrease in airflow and a >10-s cessation of airflow, and hypopnea was defined as a >30% decrease in airflow and >3% decrease in oxygen desaturation or microarousal. AHI of 5 to <15, 15 to <30, ≥30 denotes mild, moderate, and severe OSA, respectively.
Measured: Single night (8 hours)
CT
Each participant will maintain their tongues in the resting position, without swallowing, during CT. Pharyngeal airway volume, minimal cross-sectional areas, minimal distance between the lateral pharyngeal wall on both sides, and minimal distance between the anterior and posterior pharyngeal wall on the tip of the epiglottis will be measured. The detail description of each measurement are in secondary outcome measure. Experienced radiologists will perform image reconstruction and data analysis.
Measured: 10-20 minutes
Tongue muscle strength
Tongue muscle strength will be evaluated on the IOPI system (model 2.2; Northwest, Carnation, WA, USA). The participants will sit in a relaxed position, with their heads parallel to the horizontal plane and their feet on the ground. The evaluation probe will comprise a balloon and plastic catheter. The participants will squeeze the balloon for 3 s at maximum pressure. The maximum pressure of protrusion, lateralization, elevation, and depression will be considered the highest of three measurements, expressed in kilopascals.
Measured: 10 minutes
Questionnaires (including Epworth Sleepiness Scale, Pittsburgh Sleep Questionnaire Index, Snore Outcomes Survey etc.)
We will use ESS to evaluate daytime sleepiness. We will use PSQI to assess sleep quality and patterns. SOS consists of eight items related to the frequency, duration, severity, and consequences associated with sleep-disordered breathing and specifically snoring. Because of the effect of sleep-disordered breathing on partners, a separate Spouse/Bed Partner Survey (SBPS), comprising three Likert-type items, will also be used.
Measured: 10 minutes
Secondary outcomes (14)
Electroencephalography from Polysomnography (PSG)
Electroencephalogram (EEG) is a test that measures electrical activity in the brain using small, metal discs (electrodes) attached to the scalp. It will be used to determine the sleeping stages of the participants.
Measured: Single night (8 hours)
Electrooculography from Polysomnography (PSG)
Electrooculography (EOG) is a technique for measuring the corneo-retinal standing potential that exists between the front and the back of the human eye. It will be used to know the participants is in repeat eye movement stage or non-repeat eye movement stage.
Measured: Single night (8 hours)
Electromyography from Polysomnography (PSG)
Electromyography (EMG) is a technique for evaluating and recording the electrical activity produced by skeletal muscles. EMG will be used to evaluate limb movement during sleep. Surface EMG will be used in PSG.
Measured: Single night (8 hours)
Thoracic and abdominal respiratory inductance plethysmography from Polysomnography (PSG)
Thoracic and abdominal respiratory inductance plethysmography is a method of monitoring pulmonary ventilation by measuring the movement of the chest and abdominal wall. Phase relation between thorax and abdomen classifies apnea/hypopnea events into central, mixed, and obstructive types.
Measured: Single night (8 hours)
Body position sensor-modified lead II electrocardiography from Polysomnography (PSG)
It will be used to monitor the particiapants is in supine position or sidelying position.
Measured: Single night (8 hours)
Nasal cannula pressure transducer from PSG
It will be used to monitor airflow from nose and evaluate epoch of hypopnea. Airflow is in L/sec.
Measured: Single night (8 hours)
Oronasal thermistor from PSG
It will be used to monitor temperature from mouth and evaluate epoch of apnea. Temperature is in degree of celsius.
Measured: Single night (8 hours)
Finger pulse oximetry from PSG
It will be used to evaluate SpO2. SpO2 is in %.
Measured: Single night (8 hours)
Pharyngeal airway volume
Pharyngeal airway volume from the hard palate to the epiglottis will be measured. Volume in cm cubed.
Measured: 10-20 minutes
Minimal cross-sectional areas
The minimal cross-sectional areas on the tip of the epiglottis will be measured. Areas in cm.
Measured: 10-20 minutes
Minimal distance between the lateral pharyngeal wall on both sides, and minimal distance between the anterior and posterior pharyngeal wall
Minimal distance between the lateral pharyngeal wall on both sides, and minimal distance between the anterior and posterior pharyngeal wall on the tip of the epiglottis will be measured. Distance in cm.
Measured: 10-20 minutes
Epworth Sleepiness Scale (ESS)
ESS consists of eight situations measured on a scale of 0-3, representing no, occasional, common, and frequent sleepiness, respectively. The scores for the eight situations are totaled. Total scores of 0 to 10 points represent normal results, whereas total scores of 11-24 points indicate high levels of daytime sleepiness.
Measured: 5 minutes
Pittsburgh Sleep Questionnaire Index (PSQI)
It consists of nine items covering seven domains: subjective sleep quality, sleep latency, sleep duration, sleep disturbances, habitual sleep efficiency, sleep medication use, and daytime dysfunction. The participants' responses were based on the coditions in the month prior. The total scores range from 0 to 21 points, and a total score of >5 points indicates poor sleep.
Measured: 5 minutes
Snore Outcomes Survey (SOS)
SOS consists of eight items related to the frequency, duration, severity, and consequences associated with sleep-disordered breathing and specifically snoring. Because of the effect of sleep-disordered breathing on partners, a separate Spouse/Bed Partner Survey (SBPS), comprising three Likert-type items, was also used. The scores on the SOS and SBPS were normalized to the range of 0 (worst) to 100 points (best).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start17 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi-Ju, Lai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi-Ju, Lai, National Cheng Kung University
- Investigators
- Yi-Ju Lai, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115018
- Sponsor's protocol ID
- B-BR-112-052
- Status last verified
- Aug 2024
- First submitted
- 18 Oct 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other co-author in our study havn't made their decision yet.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Maintain Effect of Oropharyngeal Rehabilitation on Obstructive Sleep Apnea Patients After Palatal Surgery
- ClinicalTrials.gov ID
- NCT06115018
- Acronym / sponsor ID
- B-BR-112-052
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Oropharyngeal rehabilitation, Computed tomography, Tongue muscle strength, Maintain effect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yi-Ju, LaiUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Nov 2023 (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.
The goal of this clinical trial is to evaluate the maintain effect of palatal surgery and oropharyngeal rehabilitation (OPR) by using the severity of obstructive sleep apnea (OSA), tongue muscle strength and the space of the upper airway in patients with OSA.The main questions it aims to answer are:
- Will the severity of OSA, tongue muscle strength and the space of upper airway improve more in the palatal surgery combined OPR group than the other two groups?
- Will The maintain effect of tongue muscle strength and the space of upper airway be better in the palatal surgery combined OPR group? Participants will be divided into 3 groups including palatal surgery combined OPR group, palatal surgery group and OPR group by the doctor's advice and their willingness.The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months.
Detailed description
Background: The pathophysiology of obstructive sleep apnea (OSA) includes anatomical and non-anatomical factors. The patients who are suitable for sleep surgery may have the non-anatomical factors at the same time. Oropharyngeal rehabilitation (OPR) for the extrinsic and intrinsic muscles of the tongue might mitigate sleep apnea by preventing airway collapse and reducing the volume of the tongue base. In addition, previous studies also suggested that increasing the tension of the tongue extrinsic/intrinsic muscles may decrease the collapsibility of the upper airway and further prevent airway collapse during sleep. Although palatal surgery and OPR both can improve the severity of OSA, there is lack of literatures about the maintain effect of palatal surgery combined OPR. The aim of this study is to evaluate the maintain effect by using the severity of OSA, tongue muscle strength and the space of the upper airway. Our team have developed force sensing resistor to record the times and frequency of OPR at home from 2022. However, the investigators have to use SD card to record data in the present version. The investigators will optimize the force sensing resistor to upload data to Google Drive by using wifi. In this way, the investigators will know the daily training situation and give feedback to participants immediately by using LINE.
Methods：Seventy-five adult OSA patients will be recruited for this study. Participants will be divided into 3 groups including palatal surgery combined OPR group, palatal surgery group and OPR group by the doctor's advice and their willingness. In the palatal surgery combined OPR group, the participants will receive the palatal surgery and 3-month OPR. In the palatal surgery group and OPR group, the participants will receive palatal surgery or 3-month OPR, respectively. The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress. To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment.
Expected outcomes：
- The severity of OSA, tongue muscle strength and the space of upper airway will improve more in the palatal surgery combined OPR group than the other two groups.
- The maintain effect of tongue muscle strength and the space of upper airway is better in the palatal surgery combined OPR group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palatal surgery group | Active comparator | Procedure: Palatal surgeryIn the palatal surgery group, the participants will receive palatal surgery.To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment. |
| Oropharyngeal rehabilitation group | Active comparator | Behavioral: Oropharyngeal rehabilitationIn the oropharyngeal rehabilitation (OPR) group, the participants will receive 12-week OPR. The OPR for the OPR group included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress. To evaluate the effect of treatments on the severity of OSA, tongue muscle strength and the space of the upper airway, the participants will receive polysomonogrphy test, tongue muscle strength test and computed tomography. The time of evaluation will include baseline, 3 and 6 months after treatment. |
| Palatal surgery combined OPR group | Experimental | Combination Product: Palatal surgery combined oropharyngeal rehabilitationIn the palatal surgery combined OPR group, the participants will receive palatal surgery, then 12-week OPR. The program of OPR for this group is as the same of OPR group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild to severe obstructive sleep apnea patients
Key exclusion criteria (10 listed)
- Chronic rhinosinusitis with nasal polyps
- Adenoidal hypertrophy
- Bilateral tonsile hypertrophy
- Morbid Obesity
- Drug or alcohol abuse in one year
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 |
|---|---|---|
| Palatal surgeryPalate surgery has evolved from the ablative partial palate resections, which favored the removal of the soft tissue that obstructed the upper airway (UA), to more recent innovative reconstructive procedures that not only address the level of palatal obstruction, but the type of palatal or lateral pharyngeal wall collapse. | Procedure or surgery | Palatal surgery group |
| Oropharyngeal rehabilitationOropharyngeal rehabilitation (OPR) focus on the upper airway muscle including tongue muscle, palatal muscles and paryngeal muscles. The OPR for the treatment groups included three 30-minute sessions of OPR per day, and the exercise would be performed 3-5 days per week for 3 months. The performance of the home exercise will also be recorded by the force-sensing resistor. In addition to home exercise sessions, there will also be twice-weekly clinical visits to adjust the contents of OPR program and monitor training progress. | Behavioural | Oropharyngeal rehabilitation group |
| Palatal surgery combined oropharyngeal rehabilitationParticipants will receive palatal surgery and post-surgery oropharyngeal rehabilitation (OPR). The palatal surgery and OPR describe as above. | Combination product | Palatal surgery combined OPR group |
Primary outcome
Polysomnography (PSG)
Time frame: Single night (8 hours)
PSG will include electroencephalography, electrooculography, electromyography, thoracic and abdominal respiratory inductance plethysmography, body position sensor-modified lead II electrocardiography, oronasal thermistor, nasal cannula pressure transducer, finger pulse oximetry. The detail descriptions of each measurement are in secondary outcome measure. From the abouve measurements, OSA severity, defined using AHI, will be diagnosed by sleep medicine specialists in the ear, nose, and throat (ENT) department. AHI denotes the number of instances of apnea and hypopnea per hour during sleep. Apnea was defined as a >90% decrease in airflow and a >10-s cessation of airflow, and hypopnea was defined as a >30% decrease in airflow and >3% decrease in oxygen desaturation or microarousal. AHI of 5 to <15, 15 to <30, ≥30 denotes mild, moderate, and severe OSA, respectively.
CT
Time frame: 10-20 minutes
Each participant will maintain their tongues in the resting position, without swallowing, during CT. Pharyngeal airway volume, minimal cross-sectional areas, minimal distance between the lateral pharyngeal wall on both sides, and minimal distance between the anterior and posterior pharyngeal wall on the tip of the epiglottis will be measured. The detail description of each measurement are in secondary outcome measure. Experienced radiologists will perform image reconstruction and data analysis.
Tongue muscle strength
Time frame: 10 minutes
Tongue muscle strength will be evaluated on the IOPI system (model 2.2; Northwest, Carnation, WA, USA). The participants will sit in a relaxed position, with their heads parallel to the horizontal plane and their feet on the ground. The evaluation probe will comprise a balloon and plastic catheter. The participants will squeeze the balloon for 3 s at maximum pressure. The maximum pressure of protrusion, lateralization, elevation, and depression will be considered the highest of three measurements, expressed in kilopascals.
Questionnaires (including Epworth Sleepiness Scale, Pittsburgh Sleep Questionnaire Index, Snore Outcomes Survey etc.)
Time frame: 10 minutes
We will use ESS to evaluate daytime sleepiness. We will use PSQI to assess sleep quality and patterns. SOS consists of eight items related to the frequency, duration, severity, and consequences associated with sleep-disordered breathing and specifically snoring. Because of the effect of sleep-disordered breathing on partners, a separate Spouse/Bed Partner Survey (SBPS), comprising three Likert-type items, will also be used.
14 secondary outcomes
Electroencephalography from Polysomnography (PSG)
Time frame: Single night (8 hours)
Electrooculography from Polysomnography (PSG)
Time frame: Single night (8 hours)
Electromyography from Polysomnography (PSG)
Time frame: Single night (8 hours)
Thoracic and abdominal respiratory inductance plethysmography from Polysomnography (PSG)
Time frame: Single night (8 hours)
Body position sensor-modified lead II electrocardiography from Polysomnography (PSG)
Time frame: Single night (8 hours)
Nasal cannula pressure transducer from PSG
Time frame: Single night (8 hours)
Oronasal thermistor from PSG
Time frame: Single night (8 hours)
Finger pulse oximetry from PSG
Time frame: Single night (8 hours)
Pharyngeal airway volume
Time frame: 10-20 minutes
Minimal cross-sectional areas
Time frame: 10-20 minutes
Minimal distance between the lateral pharyngeal wall on both sides, and minimal distance between the anterior and posterior pharyngeal wall
Time frame: 10-20 minutes
Epworth Sleepiness Scale (ESS)
Time frame: 5 minutes
Pittsburgh Sleep Questionnaire Index (PSQI)
Time frame: 5 minutes
Snore Outcomes Survey (SOS)
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No. Other co-author in our study havn't made their decision yet.
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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.
Yi-Ju Lai, PhD principal investigator
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 Palatal surgery, Oropharyngeal rehabilitation and Palatal surgery combined oropharyngeal rehabilitation in people with Obstructive Sleep Apnea, run by Yi-Ju, Lai 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 1 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Aug 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Ju Lai, PhD (+886-6-2353535 ext. 4063, 11208035@gs.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography (PSG) (time frame: Single night (8 hours)). The study lists 4 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 12 Aug 2024.