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

NCT06115018 | Recruiting

• 1 other identifier: B-BR-112-052
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; Oropharyngeal rehabilitation; Computed tomography; Tongue muscle strength; Maintain effect

Outcome Measures

Primary Outcomes (4)

• 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)

• 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

• 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

• 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 Outcomes (14)

• Electroencephalography from Polysomnography (PSG)

  Single night (8 hours)

• Electrooculography from Polysomnography (PSG)

  Single night (8 hours)

• Electromyography from Polysomnography (PSG)

  Single night (8 hours)

• Thoracic and abdominal respiratory inductance plethysmography from Polysomnography (PSG)

  Single night (8 hours)

• Body position sensor-modified lead II electrocardiography from Polysomnography (PSG)

  Single night (8 hours)

Study Arms (3)

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.

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.

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.

Combination Product: Palatal surgery combined oropharyngeal rehabilitation

Interventions

Palatal surgery PROCEDURE

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.

Palatal surgery group

Oropharyngeal rehabilitation BEHAVIORAL

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.

Oropharyngeal rehabilitation group

Palatal surgery combined oropharyngeal rehabilitation COMBINATION_PRODUCT

Participants will receive palatal surgery and post-surgery oropharyngeal rehabilitation (OPR). The palatal surgery and OPR describe as above.

Palatal surgery combined OPR group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to severe obstructive sleep apnea patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Yi-Ju, Lai: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Yi-Ju Lai, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Ju Lai, PhD

CONTACT

+886-6-2353535; 11208035@gs.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Institute of Physical Education, Health and Leisure Studies, College of Management, National Cheng Kung University, Tainan, Taiwan

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 2, 2023
• Study Start: May 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)