The Influences of Intervention With Home-based Recovery Activity in Obstructive Sleep Apnea Syndrome (OSAS)
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|ClinicalTrials.gov Identifier: NCT02278094|
Recruitment Status : Unknown
Verified October 2014 by National Cheng-Kung University Hospital.
Recruitment status was: Recruiting
First Posted : October 29, 2014
Last Update Posted : October 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Tongue Muscle Trainer (TMT) Device: Threshold Inspiratory Muscle Trainer (TIMT) Procedure: Walking Exercise Device: Continuous Positive Airway Pressure (CPAP)||Not Applicable|
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.
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||September 2014|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||August 2016|
Experimental: Experimental group
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)
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.
Active Comparator: Control group
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)
CPAP regular therapy per day (use ≥ 4 h/day) then continue three to five times a week for a total of 3 months.
- Polysomnography(PSG) data in the scoring of apnea-hypopnea index (AHI), sleep stages and respiratory events. [ Time Frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention) ]The sleep efficacy will be calculated by the parameters of PSG.
- Epworth Sleepiness Score (ESS) [ Time Frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention) ]The Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness.
- WHOQOL-BREF(EQ-5D) questionnaire [ Time Frame: Baseline , post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention) ]The utility value of the QOL for patients on Prolonged Mechanical Ventilation (PMV) was estimated using the EuroQol five-dimensional (EQ-5D) questionnaire, which is a generic preference-based instrument.
- 6MWD( = 6MWT) [ Time Frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention) ]The 6-min walk test (6MWT), which is a cheap and simple examination to perform, is now regarded as a standard tool to measure submaximal exercise capacity in patients with cardiopulmonary disease.
- RPE [ Time Frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention) ]Ratings of perceived exertion (or "effort and exertion") are important complements toward physiological measurements. Of all the single indicators of the degree of physical strain, perceived exertion is one of the most directive measures.
- Flow-volume loop (FV-Loop) [ Time Frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention) ]The flow-volume curve is important and may help interpret pulmonary symptoms or upper airway diseases.
- Tongue Muscle Strength [ Time Frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention) ]The measurement of tongue strength contributes to the study of oro-facial physiology.
- Anthropometric data [ Time Frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention) ]Anthropometric measurements including height, weight, and circumference measurements were obtained before and after the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278094
|Contact: Lin Huei-Chen, PTemail@example.com|
|Contact: Ong Jun-Hui, PTfirstname.lastname@example.org|
|Tainan Hospital (Ministry of Health and Welfare)||Recruiting|
|Tainan, Taiwan, 70043|
|Contact: Lin Cheng-Yu +886-6-2200055 ext 3383|
|Principal Investigator:||Hung Ching-Hsia, PT||National Cheng Kung University|