The Efficacy and Maintain Effect of OPR on OSA Patients After Palatal Surgery

Obstructive Sleep Apnea Clinical Trial

Official title:

The Efficacy and Maintain Effect of Oropharyngeal Rehabilitation on Obstructive Sleep Apnea Patients After Palatal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06115018
• Other study ID #: B-BR-112-052
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: March 2024
• Source: National Cheng Kung University
• Contact: Yi-Ju Lai, PhD
• Phone: +886-6-2353535
• Email: 11208035[@]gs.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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?

2. 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.

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：

1. 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.

2. The maintain effect of tongue muscle strength and the space of upper airway is better in the palatal surgery combined OPR group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• mild to severe obstructive sleep apnea patients

Exclusion Criteria:

• Chronic rhinosinusitis with nasal polyps

• Adenoidal hypertrophy

• Bilateral tonsile hypertrophy

• Morbid Obesity

• Drug or alcohol abuse in one year

• Pregnancy

• Severe lung disease

• Heart disease with high risk of exercise

• Neuromuscular disease that can't follow the exercise program

• Central or mixed sleep apnea

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Palatal 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.

Behavioral:
• Oropharyngeal rehabilitation
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.

Combination Product:
• Palatal surgery combined oropharyngeal rehabilitation
Participants will receive palatal surgery and post-surgery oropharyngeal rehabilitation (OPR). The palatal surgery and OPR describe as above.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yi-Ju, Lai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Single night (8 hours)
Primary	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.	10-20 minutes
Primary	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.	10 minutes
Primary	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.	10 minutes
Secondary	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.	Single night (8 hours)
Secondary	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.	Single night (8 hours)
Secondary	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.	Single night (8 hours)
Secondary	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.	Single night (8 hours)
Secondary	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.	Single night (8 hours)
Secondary	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.	Single night (8 hours)
Secondary	Oronasal thermistor from PSG	It will be used to monitor temperature from mouth and evaluate epoch of apnea. Temperature is in degree of celsius.	Single night (8 hours)
Secondary	Finger pulse oximetry from PSG	It will be used to evaluate SpO2. SpO2 is in %.	Single night (8 hours)
Secondary	Pharyngeal airway volume	Pharyngeal airway volume from the hard palate to the epiglottis will be measured. Volume in cm cubed.	10-20 minutes
Secondary	Minimal cross-sectional areas	The minimal cross-sectional areas on the tip of the epiglottis will be measured. Areas in cm.	10-20 minutes
Secondary	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.	10-20 minutes
Secondary	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.	5 minutes
Secondary	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.	5 minutes
Secondary	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).	5 minutes