The Influences of Intervention With Home-based Recovery Activity in Obstructive Sleep Apnea Syndrome

Summary

Background: OSAS is a type of sleep disorder characterized by intermittent, partial or complete upper airway (UA) collapse, seriously impacting sleep apnea and respiratory insufficiency. The major upper airway dilator muscle (genioglossus) is more active during periods of stable breathing compared with periods of cyclical breathing when obstructive apneas occurred. UA muscle strength is linearly related to the inspiratory pump muscle strength. The ratios of UA muscle strength (tongue protrusion, TP) and inspiratory pump muscle strength (PImax) were not different between individuals with and without OSAS. However, a highly wakeful ratio of TP force to PImax appears to be associated with a reduced propensity to moderate-to-severe OSAS. Up to 95% of OSAS cases are treated with continuous positive airway pressure (CPAP), which is the most effective, commonly used, and low-risk treatment method. However, patients using CPAP therapy could face ongoing difficulties. Aims: To evaluate the effects of home-based exercise for patients with moderate to severe OSAS. This study was a randomized clinical trial conducted at three different intervention protocols as experimental groups. We will use cluster random sampling assign to each group. CPAP treatment group will be the control group. Methods: Subject above 20 years old will be diagnosed to moderate and severe OSAS. Subjects will be assign to walking exercise (WE), Threshold Inspiratory Muscle Trainer (TIMT) and Tongue Muscle Trainer (TMT) treatment groups. We will compare the Polysomnography (PSG) data, Epworth Sleepiness scale (ESS), World Health Organization Quality of Life( WHOQOL) questionnaire is a shorter version of the original instrument (WHOQOL-BREF), 6-minute walking test (6MWD), rate of perceived exertion scale (RPE), flow-volume loop (FV-Loop), tongue and grasp muscle strength, anthropometric data and daily note at baseline, 3 months (end-of-intervention) and 6 months (post intervention follow-up) in patients with moderate to severe OSAS. They will undergo three months of the home-based exercises. Patients will be followed up with weekly telephone calls and be interviewed monthly. Expected results: By using the WE, TIMT and TMT therapies, the airway collapse during sleep will be prevented when the whole body muscle strength, inspiratory pump muscle strength and tongue muscle strength are enhanced.

Conditions

• Obstructive Sleep Apnea

Interventions

DEVICE

Tongue Muscle Trainer (TMT)

Subject will be instructed to compress the Iowa Oral Performance Instrument (IOPI) IOPI's bulb using tongue in three directions (anterior and both lateral sides). Then, hold 30-35 seconds each time. Subjects will be encouraged to do 60 minutes of exercise daily then continue three to five times a week for a total of 3 months.

DEVICE

Threshold Inspiratory Muscle Trainer (TIMT)

Resistance of the TIMT devices will be set from 30% of the maximum inspiratory pressure. Nose clip follow by normal breathing. Seal the mouth to the device's mouth piece then inhale through the device. Subjects will be encouraged to do 60 minutes of exercise daily then continue three to five times a week for a total of 3 months.

PROCEDURE

Walking Exercise

Subjects will be encouraged to perform walking exercise in the field 10000 steps/ 60 minutes daily then continue three to five times a week during first months. Followed by 12500 steps and 15000steps per day during the second and third months.

DEVICE

Continuous Positive Airway Pressure (CPAP)

CPAP regular therapy per day (use ≥ 4 h/day) then continue three to five times a week for a total of 3 months.

Sponsors & Collaborators

• National Cheng-Kung University Hospital

  lead OTHER

Principal Investigators

• Hung Ching-Hsia, PT · National Cheng Kung University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2020-05-31

Completion

2020-08-31

Countries

• Taiwan

Study Locations