Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Lin Huei-Chen, PT +886-9-33123344 hclin2@ms.szmc.edu.tw
Contact: Ong Jun-Hui, PT +886-9-88847891 junhui5252@yahoo.com

Locations
Layout table for location information
Taiwan
Tainan Hospital (Ministry of Health and Welfare) Recruiting
Tainan, Taiwan, 70043
Contact: Lin Cheng-Yu    +886-6-2200055 ext 3383      
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hung Ching-Hsia, PT National Cheng Kung University

Layout table for additonal information
Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02278094    
Other Study ID Numbers: --/A-ER-103-168
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by National Cheng-Kung University Hospital:
OSAS
Adult
Home-based
Genioglossus
Inspiratory muscle
Exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases