Obstructive Sleep ApneaOSASNCT02278094
The Influences of Intervention With Home-based Recovery Activity in Obstructive Sleep Apnea Syndrome
A study testing Tongue Muscle Trainer (TMT), Threshold Inspiratory Muscle Trainer (TIMT) and Walking Exercise in people with Obstructive Sleep Apnea, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Tongue Muscle Trainer (TMT), Threshold Inspiratory Muscle Trainer (TIMT) and Walking Exercise
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2014to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to exercise
- Exercise-induced myocardial ischemia
- Chronic pulmonary disease
- Stroke
- Peripheral arterial disease
- Severe psychiatric disorder (e.g. bipolar disorder, schizophrenia)
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study to Examine the Effect of Home-based Recovery Activity in Moderate to Severe Obstructive Sleep Apnea Syndrome Patients
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Tongue Muscle Trainer (TMT), Threshold Inspiratory Muscle Trainer (TIMT), Walking Exercise, Continuous Positive Airway Pressure (CPAP)
- Keywords
- OSAS, Adult, Home-based, Genioglossus, Inspiratory muscle, Exercise
- Medical subject headings
- Sleep Apnea, Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Walking ExerciseProcedure or surgery
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Secondary outcomes (7)
Epworth Sleepiness Score (ESS)
The Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness.
Measured: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
WHOQOL-BREF(EQ-5D) questionnaire
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.
Measured: Baseline , post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
6MWD( = 6MWT)
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.
Measured: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
RPE
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.
Measured: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Flow-volume loop (FV-Loop)
The flow-volume curve is important and may help interpret pulmonary symptoms or upper airway diseases.
Measured: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Tongue Muscle Strength
The measurement of tongue strength contributes to the study of oro-facial physiology.
Measured: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Anthropometric data
Anthropometric measurements including height, weight, and circumference measurements were obtained before and after the study.
Measured: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung Ching-Hsia, PT, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278094
- Sponsor's protocol ID
- --/A-ER-103-168
- Acronym
- OSAS
- Status last verified
- Mar 2024
- First submitted
- 28 Sep 2014
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Examine the Effect of Home-based Recovery Activity in Moderate to Severe Obstructive Sleep Apnea Syndrome Patients
- ClinicalTrials.gov ID
- NCT02278094
- Acronym / sponsor ID
- OSAS / --/A-ER-103-168
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSAS, Adult, Home-based, Genioglossus, Inspiratory muscle, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Tongue Muscle Trainer (TMT), Device: Threshold Inspiratory Muscle Trainer (TIMT), Procedure: Walking ExerciseSubjects will be in random cluster assign to walking exercise (WE), Threshold Inspiratory Muscle Trainer (TIMT) and Tongue Muscle Trainer (TMT) treatment groups. |
| Control group | Active comparator | Device: Continuous Positive Airway Pressure (CPAP)Up to 95% of OSAS cases are treated with continuous positive airway pressure (CPAP), CPAP treatment group will be the control group. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- Inability to exercise
- Exercise-induced myocardial ischemia
- Chronic pulmonary disease
- Stroke
- Peripheral arterial disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Experimental group |
| 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. | Device | Experimental group |
| Walking ExerciseSubjects 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. | Procedure or surgery | Experimental group |
| 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. | Device | Control group |
Primary outcome
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.
7 secondary outcomes
Epworth Sleepiness Score (ESS)
Time frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
WHOQOL-BREF(EQ-5D) questionnaire
Time frame: Baseline , post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
6MWD( = 6MWT)
Time frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
RPE
Time frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Flow-volume loop (FV-Loop)
Time frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Tongue Muscle Strength
Time frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Anthropometric data
Time frame: Baseline, post-intervention (3 months) and post-intervention follow (6 months after ceasation of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung Ching-Hsia, PT principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue Muscle Trainer (TMT), Threshold Inspiratory Muscle Trainer (TIMT) and Walking Exercise in people with Obstructive Sleep Apnea, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.