Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery

NCT04876482 | Completed Results

• 1 other identifier: NCKUH-10902002
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Obstructive Sleep Apnea Syndrome (OSA) is a kind of sleep disorder. The symptoms are intermittent, partial or complete upper airway collapse, seriously impacting oxygen saturation and oxidative stress. Some patients choose to do upper airway surgeries, but the success rate is only 60-70%. The symptoms might relapse because of aging and gaining weights. The purpose of our study is to compare the effect of transoral robotic surgery (TORS) and oropharyngeal rehabilitation (OPR) on patients after TORS. Methods: Participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index \>5/h), and the physician will explain the treatment programs to every subject in clinic. Expected results: The hypothesis of this study is the success rate of surgery will be enhance by increasing tongue and jaw-opening muscle strength after OPR. The biomarkers of cardiovascular disease may decrease and both the collapse of upper airway and sleep quality may be improved after TORS and OPR.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (11)

• Apnea Hypopnea Index (AHI)

  Polysomnography included electroencephalographic, electro-oculographic, thoracic and abdominal respiratory inductance plethysmography and body position sensor to confirm the sleeping stage in one-night observation. Above measurements will be aggregated to arrive AHI. Unabbreviated scale title:Apnea and Hypopnea index The minimum value:0 The maximum values: none Higher scores mean a worse outcome.

  through study completion, an average of 6 months

• Computer Tomography (CT)_Volume

  All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Volume from hard palate to the base of epiglottis was measured.

  through study completion, an average of 6 months

• Computer Tomography (CT)_minimal Area

  All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Cross section area on the tip of epiglottis was measured.

  through study completion, an average of 6 months

• Computer Tomography (CT)_AP Distance

  All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Anterior to posterior distance on the tip of epiglottis was measured.

  through study completion, an average of 6 months

• Computer Tomography (CT)_Lateral Distance

  All patients underwent CT in a supine position. Each patient was instructed to maintain his/her tongue in the resting position, without swallowing, during CT. Lateral distance on the tip of epiglottis was measured.

  through study completion, an average of 6 months

• Drug-induced Sleep Endoscopy (DISE)

  All patients underwent DISE in a supine position. The possible outcomes were unilevel collapse at the velum, oropharynx, tongue base, or epiglottis and multilevel collapse at any of these locations. The velum is the part of the upper airway at the level of the soft palate and uvula; the oropharynx is the pharyngeal portion at the level of the tonsils, above the tongue base. The tongue base was considered the retroglossal area; epiglottis was considered the pharyngeal region below the tongue base. The degree of obstruciton was diagnosed by an ear nose throat surgeon. The degree of obstruction ranged from 0 to 2. 0: no obstruction (\<50%); 1: partial obstruction (50-75%); 2: complete obstruction (\>75%).

  through study completion, an average of 6 months

• Jaw Opening Muscle Strength

  Muscle strength of jaw was measured with a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA) mounted on an adapted ophthalmic examination frame, to avoid alterations in chin and head position and to ensure consistent compression.

  through study completion, an average of 6 months

• Tongue Protrusion Muscle Strength

  The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).

  through study completion, an average of 6 months

• Tongue Elevation Muscle Strength

  The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).

  through study completion, an average of 6 months

• Tongue Depression Muscle Strength

  The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).

  through study completion, an average of 6 months

• Tongue Lateralization Muscle Strength

  The muscle strength of the tongue was evaluated by the IOPI system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA).

  through study completion, an average of 6 months

Study Arms (3)

Control

SHAM COMPARATOR

Without the willingness of surgery, those participants waiting for oral appliance (Device), losing weights and using continuous positive airway pressure (Device) were distribute to control group.

Device: oral appliance; Device: using continuous positive airway pressure; Behavioral: losing weights

Transoral robotic surgery (TORS)

EXPERIMENTAL

The participants underwent TORS. TORS is a kind of surgery that the surgeons would remove the tonsils and the fat tissue of tongue base and suspend the soft palate.

Procedure: transoral robotic surgery

TORS+OPR

EXPERIMENTAL

The participants started OPR 6 weeks after TORS. Each exercise was repeated 10 times, 1-3 cycles per day, 3-5 sessions per week at their home and performed for 3 months. Patients were supervised by physical therapist once a week for 30 minutes.

Procedure: transoral robotic surgery; Combination Product: oropharyngeal rehabilitation

Interventions

transoral robotic surgery PROCEDURE

transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study

TORS+OPR; Transoral robotic surgery (TORS)

oral appliance DEVICE

It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.

Control

using continuous positive airway pressure DEVICE

The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.

Also known as: CPAP

Control

losing weights BEHAVIORAL

The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.

Control

oropharyngeal rehabilitation COMBINATION_PRODUCT

OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.

Also known as: OPR

TORS+OPR

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of mild to severe OSA in the past year
• Age between 20-65 years old.

You may not qualify if:

• A history of malignancy or infection of the head and neck region and laryngeal trauma
• Craniofacial malformation
• Stroke
• Neuromuscular disease
• Heart failure
• Coronary artery disease.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Please Select, 412, Taiwan

Location

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

Limitations and Caveats

1. The small sample size of 78 participants with OSA, a higher number of male participants, and the inclusion of only participants of Asian ethnicity 2. Including patients who appeared motivated to undergo OPR in Group SO was likely to exaggerate the effectiveness of OPR because the patients might increase the frequency of OPR 3. Participant compliance in home-based exercise was monitored mainly through self-report 4. The intervention period of our OPR protocol was only 12 weeks.

Results Point of Contact

• Title: Yi-Ju, Lai
• Organization: Department of Physical Therapy, Shu-Zen Junior College of Medicine and Management, Kaohsiung, Taiwan

jasmine19900728@gmail.com

+886963123117

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: May 6, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)