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

NCT02278094 | Completed

• 1 other identifier: --/A-ER-103-168
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

OSAS; Adult; Home-based; Genioglossus; Inspiratory muscle; Exercise

Outcome Measures

Primary Outcomes (1)

• Polysomnography(PSG) data in the scoring of apnea-hypopnea index (AHI), sleep stages and respiratory events.

  The sleep efficacy will be calculated by the parameters of PSG.

  Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)

Secondary Outcomes (7)

• Epworth Sleepiness Score (ESS)

  Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)

• WHOQOL-BREF(EQ-5D) questionnaire

  Baseline , post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)

• 6MWD( = 6MWT)

  Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)

• RPE

  Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)

• Flow-volume loop (FV-Loop)

  Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)

Study Arms (2)

Experimental group

EXPERIMENTAL

Subjects will be in random cluster assign to walking exercise (WE), Threshold Inspiratory Muscle Trainer (TIMT) and Tongue Muscle Trainer (TMT) treatment groups.

Device: Tongue Muscle Trainer (TMT); Device: Threshold Inspiratory Muscle Trainer (TIMT); Procedure: Walking Exercise

Control group

ACTIVE COMPARATOR

Up to 95% of OSAS cases are treated with continuous positive airway pressure (CPAP), CPAP treatment group will be the control group.

Device: Continuous Positive Airway Pressure (CPAP)

Interventions

Tongue Muscle Trainer (TMT) DEVICE

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.

Experimental group

Threshold Inspiratory Muscle Trainer (TIMT) DEVICE

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.

Experimental group

Walking Exercise PROCEDURE

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.

Experimental group

Continuous Positive Airway Pressure (CPAP) DEVICE

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

Control group

Eligibility Criteria

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

You may qualify if:

• Mean aged ≥20 years old,
• Good general health (stability of clinic state)
• Epworth Sleepiness Scale ≥ 10
• PSG for discriminate moderate to severe subjects (AHI≧15 h-1)
• Presence of excessive daytime somnolence (EDS)
• From the community and hospital

You may not qualify if:

• Inability to exercise
• Exercise-induced myocardial ischemia
• Chronic pulmonary disease
• Stroke
• Peripheral arterial disease
• Severe psychiatric disorder (e.g. bipolar disorder, schizophrenia)
• Tensile hypertrophy
• Pregnancy
• Alcoholism (≥ 50 gm per day)
• Active or uncontrolled chronic medical condition (e.g., cardio-respiratory disease, diabetes mellitus, endocrine disorders, stroke, abnormal pulmonary function, morbid obesity, renal disease, hypertension (i.e., \>159/99 mm Hg), myopathy, neurologic illness, recent infection , and recent (\< 3 months) myocardial infarction, or angina).

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Tainan Hospital (Ministry of Health and Welfare)

Tainan, 70043, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Motor Activity

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Hung Ching-Hsia, PT

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 28, 2014
• First Posted: October 29, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

TW (1)