Menu
Recruiting NCT06115018

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

No phase Interventional Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Palatal surgery, Oropharyngeal rehabilitation, Palatal surgery combined oropharyngeal rehabilitation.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 an
  • 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.

Primary outcome measures

  • Polysomnography (PSG) [Time frame: Single night (8 hours)]
  • CT [Time frame: 10-20 minutes]
  • Tongue muscle strength [Time frame: 10 minutes]
  • Questionnaires (including Epworth Sleepiness Scale, Pittsburgh Sleep Questionnaire Index, Snore Outcomes Survey etc.) [Time frame: 10 minutes]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Cheng Kung University Hospital — Tainan

Identifiers

NCT: NCT06115018 · B-BR-112-052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗