Clinical trial NCT06115018: The Efficacy and Maintain Effect of OPR on OSA Patients After Palatal Surgery
Official title: The Efficacy and Maintain Effect of Oropharyngeal Rehabilitation on Obstructive Sleep Apnea Patients After Palatal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Oropharyngeal rehabilitation
Computed tomography
Tongue muscle strength
Maintain effect
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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：

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.

Eligibility criteria: 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

Primary outcomes:
measure: Polysomnography (PSG)
timeFrame: Single night (8 hours)
measure: CT
timeFrame: 10-20 minutes
measure: Tongue muscle strength
timeFrame: 10 minutes
measure: Questionnaires (including Epworth Sleepiness Scale, Pittsburgh Sleep Questionnaire Index, Snore Outcomes Survey etc.)
timeFrame: 10 minutes
Secondary outcomes:
measure: Electroencephalography from Polysomnography (PSG)
timeFrame: Single night (8 hours)
measure: Electrooculography from Polysomnography (PSG)
timeFrame: Single night (8 hours)
measure: Electromyography from Polysomnography (PSG)
timeFrame: Single night (8 hours)
measure: Thoracic and abdominal respiratory inductance plethysmography from Polysomnography (PSG)
timeFrame: Single night (8 hours)
measure: Body position sensor-modified lead II electrocardiography from Polysomnography (PSG)
timeFrame: Single night (8 hours)
measure: Nasal cannula pressure transducer from PSG
timeFrame: Single night (8 hours)
measure: Oronasal thermistor from PSG
timeFrame: Single night (8 hours)
measure: Finger pulse oximetry from PSG
timeFrame: Single night (8 hours)
measure: Pharyngeal airway volume
timeFrame: 10-20 minutes
measure: Minimal cross-sectional areas
timeFrame: 10-20 minutes
measure: Minimal distance between the lateral pharyngeal wall on both sides, and minimal distance between the anterior and posterior pharyngeal wall
timeFrame: 10-20 minutes
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 5 minutes
measure: Pittsburgh Sleep Questionnaire Index (PSQI)
timeFrame: 5 minutes
measure: Snore Outcomes Survey (SOS)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University
name: Yi-Ju Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References: