Obstructive Sleep Apnea of AdultNCT03940781
Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
A study testing comprehensive rehabilitation in people with Obstructive Sleep Apnea of Adult, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- comprehensive rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2017to 22 Mar 2019
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 35-65 with or without surgery had difficulty accepting or adhering CPAP
Who cannot join
- BMI<32
- Smoking or alcoholism
- Severe allergic rhinitis
- Stroke history
- CVD
- Severe restricted or obstructive pulmonary disease
Show all 10Show fewer
- Hypothyroidism
- DM or HTN without stable control
- Psychiatric disease
- Co-existing non-respiratory sleep disorders
Trial locations and contacts
1 site in 1 country.
About this study
In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a comprehensive rehabilitation model is of innovative care strategy in this study.
Read the detailed description
BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder, which was characterized by repetitive events of complete and partial obstructions of the upper airway. The pathogenesis of OSA is interacted by multiple factors, primarily including upper airway (UA) anatomic impairment, ventilatory drive instability, and oropharyngeal muscle dysfunction. However, studies have proven prior oropharyngeal exercise was designed for those OSA patients with oropharyngeal muscle dysfunction. Unlike prior oropharyngeal exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation capability in addition to oropharyngeal function.
OBJECTIVES: Therefore, the purpose of this study is to explore both the clinical and biological effects of our comprehensive rehabilitation, we used PSG data as clinical effect and biomarker of inflammation expression as biological effect.
METHODS: Thirty subjects with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15). In intervention group, a 12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle training, threshold respiratory muscle training, and therapeutic exercise.
ANTICIPATED OUTCOMES: The preliminary results would demonstrate promisingly clinical effects and biological effects of our comprehensive rehabilitation model. Therefore, the further studies should emphasize the methods to differentiate diagnosis for the indicated patients with oropharyngeal muscle dysfunction or ventilatory drive instability.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- comprehensive rehabilitation
- Keywords
- obstructive sleep apnea, oropharyngeal rehabilitation, cardiopulmonary rehabilitation
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive rehabilitationBehavioural
oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation' Receives: Behavioral: comprehensive rehabilitation |
| control group | No intervention | We kept the patients for the waiting list until after completing baseline and 12-week measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopea-index
average apnea and hypopnea events per hour during sleep test
Measured: Change from Baseline Apnea-hypopnea-index at 12 weeks
potential biomarkers of endothelial dysfunction
count of ICAM-1, VCAM-1, and NF-κB molecule in plasma serum (%)
Measured: at 12 weeks
Secondary outcomes (4)
Oropharyngeal muscle function
myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles
Measured: at 12 weeks
Respiratory muscle function
PImax(mmH2O), PEmax(mmH2O)
Measured: at 12 weeks
Respiratory muscle function
pulmonary function test (FVC%,FEV1%,FEF50%,FIF50%)
Measured: at 12 weeks
Hear rate variability
time domain and frequency domain HRV
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Sep 2017
- Primary completion28 Feb 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ching-Hsia Hung, National Cheng-Kung University Hospital
- Investigators
- Chinghsia Hung, PhD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940781
- Sponsor's protocol ID
- NCKUH-10802018
- Status last verified
- May 2019
- First submitted
- 10 Jan 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03940781
- Acronym / sponsor ID
- NCKUH-10802018
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- obstructive sleep apnea, oropharyngeal rehabilitation, cardiopulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 7 May 2019 (actual)
- 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.
In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a comprehensive rehabilitation model is of innovative care strategy in this study.
Detailed description
BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder, which was characterized by repetitive events of complete and partial obstructions of the upper airway. The pathogenesis of OSA is interacted by multiple factors, primarily including upper airway (UA) anatomic impairment, ventilatory drive instability, and oropharyngeal muscle dysfunction. However, studies have proven prior oropharyngeal exercise was designed for those OSA patients with oropharyngeal muscle dysfunction. Unlike prior oropharyngeal exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation capability in addition to oropharyngeal function.
OBJECTIVES: Therefore, the purpose of this study is to explore both the clinical and biological effects of our comprehensive rehabilitation, we used PSG data as clinical effect and biomarker of inflammation expression as biological effect.
METHODS: Thirty subjects with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15). In intervention group, a 12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle training, threshold respiratory muscle training, and therapeutic exercise.
ANTICIPATED OUTCOMES: The preliminary results would demonstrate promisingly clinical effects and biological effects of our comprehensive rehabilitation model. Therefore, the further studies should emphasize the methods to differentiate diagnosis for the indicated patients with oropharyngeal muscle dysfunction or ventilatory drive instability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: comprehensive rehabilitationWe conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation' |
| control group | No intervention | –We kept the patients for the waiting list until after completing baseline and 12-week measurement |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 35-65 with or without surgery had difficulty accepting or adhering CPAP
Key exclusion criteria (10 listed)
- BMI<32
- Smoking or alcoholism
- Severe allergic rhinitis
- Stroke history
- CVD
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 |
|---|---|---|
| comprehensive rehabilitationoropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise | Behavioural | intervention group |
Primary outcome
Apnea-hypopea-index
Time frame: Change from Baseline Apnea-hypopnea-index at 12 weeks
average apnea and hypopnea events per hour during sleep test
potential biomarkers of endothelial dysfunction
Time frame: at 12 weeks
count of ICAM-1, VCAM-1, and NF-κB molecule in plasma serum (%)
4 secondary outcomes
Oropharyngeal muscle function
Time frame: at 12 weeks
Respiratory muscle function
Time frame: at 12 weeks
Respiratory muscle function
Time frame: at 12 weeks
Hear rate variability
Time frame: at 12 weeks
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 7 May 2019.
- Individual participant dataSharing planned: No
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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.
Chinghsia Hung, PhD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive rehabilitation in people with Obstructive Sleep Apnea of Adult, 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 1 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 7 May 2019. 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?
Apnea-hypopea-index (time frame: Change from Baseline Apnea-hypopnea-index at 12 weeks). The study lists 2 primary outcomes in all. 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 7 May 2019.