Clinical trial NCT02278094: The Influences of Intervention With Home-based Recovery Activity in Obstructive Sleep Apnea Syndrome
Official title: A Randomized Controlled Study to Examine the Effect of Home-based Recovery Activity in Moderate to Severe Obstructive Sleep Apnea Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: OSAS
Adult
Home-based
Genioglossus
Inspiratory muscle
Exercise
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Obstructive sleep apnea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB) characterized by repetitive episodes of cessation of breathing during sleep due to upper airway collapse. It causes sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor quality of life. In addition, OSAS is associated with non-fatal and fatal cardiovascular consequences including sudden death as well as to an increased risk of road traffic accidents. OSAS is a common disease, affecting approximately 2% of women and 4% of men residing in Western communities.

Risk factors for OSAS include obesity, aging, particularly males, abnormal craniofacial morphology, nasal obstruction, and genetic factors. OSAS is associated with several cardiovascular consequences and social consequences such as motor vehicle accidents, impaired cognitive performance, and depression. Various epidemiologic studies have shown an association between OSAS and hypertension. In a cross-sectional study, OSAS was associated with increased prevalence of self-reported heart failures and strokes. OSAS has been shown to be independently associated with coronary artery disease after adjustment for traditionally considered risk factors.

According to the American Medical Association in 2013, obstructive sleep apnea syndrome (OSAS) is a common disorder that affects everyone in all ages, especially middle-aged and elderly people. In fact, evidence showed that OSAS rates had been increasing due to the escalation of obesity rates. Thus, the goal of the OSAS treatment is to alleviate the airway obstruction during sleep. The standard first-line OSAS treatment involves continuous positive airway pressure (CPAP) devices, which deliver compressed air into the airway in order to stay open. In most cases, many patients cannot tolerate CPAP and often are unable to adhere to the instructions for many reasons. Patients began to feel discomfort and claustrophobic as well as skin irritation and noise. Although small studies lack data of other OSAS treatments, this case resulted in insufficient evidence to determine the efficacy of these strategies. In regards to limited data, the evidence is not yet resolved on the effectiveness of the treatment. There is very limited evidence on the clinical outcomes of the OSAS intervention, and most of the data focus on immediate results that are exceedingly direct and provide no long-term benefits. Likewise, evidence in evaluating the relative efficacy of weight loss, oronasopharyngeal exercise and tongue retraining device interventions for OSAS treatment was insufficient. Low-quality evidence indicated that the above interventions improved sleep measures and should be recommended for patients with OSAS.

Purpose:

The aim of the study was to assess the effect of PSG data, Epworth Sleepiness scale (ESS), WHOQOL-BREF questionnaire (EQ-5D), 6-minute walking test (6MWD), rate of perceived exertion scale (RPE), flow-volume loop (FV-Loop), tongue and grasp muscle strengths, anthropometric data and daily note record between two groups (control group: CPAP therapy and experimental group: subgroup have WE, TIMT and TMT therapies) patients with moderate to severe obstructive sleep apnea syndrome (OSAS).

Hypothesis:

The investigators hypothesize that more moderate to severe obstructive sleep apnea syndrome patients in a home-based recovery activity intervention program will have improved PSG data, quality of life, exercise ability, pulmonary function, muscle strength, anthropometric data and daily note record than patients receiving CPAP alone.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Polysomnography(PSG) data in the scoring of apnea-hypopnea index (AHI), sleep stages and respiratory events.
timeFrame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Secondary outcomes:
measure: Epworth Sleepiness Score (ESS)
timeFrame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
measure: WHOQOL-BREF(EQ-5D) questionnaire
timeFrame: Baseline , post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
measure: 6MWD( = 6MWT)
timeFrame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
measure: RPE
timeFrame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
measure: Flow-volume loop (FV-Loop)
timeFrame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
measure: Tongue Muscle Strength
timeFrame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
measure: Anthropometric data
timeFrame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Tainan Hospital (Ministry of Health and Welfare)
Study officials:
affiliation: National Cheng Kung University
name: Hung Ching-Hsia, PT
role: PRINCIPAL_INVESTIGATOR
References: