OSANCT04626700
Comparison for Oral Negative Pressure Therapy and CPAP for OSA Under Sleep Endoscopy Assistance: A Randomized Controlled Trial
A study testing iNAP and CPAP in people with OSA and iNAP, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This is the study entitled "Comparison for oral negative pressure therapy and CPAP for OSA under sleep endoscopy assistance: A randomized controlled trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is poor. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- iNAP and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2019to 30 Jun 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to moderate OSA
Who cannot join
- hypopharynx obstruction
- ASA classification of physical status)>3
- allergy toDexmedetomidine
- COPD stage IV
- Asthma with exacerbation
- severe CHF
Show all 10Show fewer
- age < 18 year-old
- claustraphobia
- any reason : can not tolerate CPAP
- second or third degree AVB
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of Thoracic Medicine, Chang Gung Memorial Hospital
Taipei, 105
TSAI-YU WANG, MD, 886-03-3281200 ext. 8467, wang5531@gmail.com
About this study
Official title: Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch
This is the study entitled "Comparison for oral negative pressure therapy and CPAP for OSA under sleep endoscopy assistance: A randomized controlled trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is poor. Recent study reveals that oral negative pressure therapy improves apnea severity in OSA patients with good compliance. However, no study is designed to compare oral negative pressure therapy and CPAP for OSA patients. In addition, the effect of oral negative pressure therapy for hypopharynx is unclear. Therefore, we will perform druginduced sleep endoscopy to evaluate upper airway obstruction of OSA patients before treatment. OSA patients will be assigned into oral negative pressure group or CPAP group for 2 months. Sleepiness, sleep quality, residual apnea severity and compliance will be evaluated.
- Being tested
- iNAP, CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNAPDevice
iNAP for the treatment of OSA
CPAPDevice
CPAP for the treatment of OSA
| Study group | Role | What they receive |
|---|---|---|
| iNAP | Experimental | Not described Receives: Device: iNAP |
| CPAP | Active comparator | Not described Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Epworth Sleepiness Scale (ESS)
lower ESS means better outcome
Measured: Change from Baseline ESS at 1 month
The Epworth Sleepiness Scale (ESS)
lower ESS means better outcome
Measured: Change from Baseline ESS at 2 months
apnea-hypopnea index (AHI)
lower AHI means better outcome
Measured: Change from Baseline AHI at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start14 Aug 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsang-Tang Hsieh, MD, Study chair, Institutional Review Board Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626700
- Sponsor's protocol ID
- 201802177A3
- Status last verified
- Oct 2020
- First submitted
- 1 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch
- ClinicalTrials.gov ID
- NCT04626700
- Acronym / sponsor ID
- 201802177A3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 12 Nov 2020 (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.
This is the study entitled "Comparison for oral negative pressure therapy and CPAP for OSA under sleep endoscopy assistance: A randomized controlled trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is poor. Recent study reveals that oral negative pressure therapy improves apnea severity in OSA patients with good compliance. However, no study is designed to compare oral negative pressure therapy and CPAP for OSA patients. In addition, the effect of oral negative pressure therapy for hypopharynx is unclear. Therefore, we will perform druginduced sleep endoscopy to evaluate upper airway obstruction of OSA patients before treatment. OSA patients will be assigned into oral negative pressure group or CPAP group for 2 months. Sleepiness, sleep quality, residual apnea severity and compliance will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iNAP | Experimental | Device: iNAP |
| CPAP | Active comparator | Device: CPAP |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild to moderate OSA
Key exclusion criteria (10 listed)
- hypopharynx obstruction
- ASA classification of physical status)>3
- allergy toDexmedetomidine
- COPD stage IV
- Asthma with exacerbation
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 |
|---|---|---|
| iNAPiNAP for the treatment of OSA | Device | iNAP |
| CPAPCPAP for the treatment of OSA | Device | CPAP |
Primary outcome
The Epworth Sleepiness Scale (ESS)
Time frame: Change from Baseline ESS at 1 month
lower ESS means better outcome
The Epworth Sleepiness Scale (ESS)
Time frame: Change from Baseline ESS at 2 months
lower ESS means better outcome
apnea-hypopnea index (AHI)
Time frame: Change from Baseline AHI at 2 months
lower AHI means better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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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.
Tsang-Tang Hsieh, MD study chair
Institutional Review Board Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iNAP and CPAP in people with OSA and iNAP, run by Chang Gung Memorial 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: status not confirmed, as of the sponsor's last update on 12 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsai-Yu Wang, MD (+886975368076, wang5531@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Epworth Sleepiness Scale (ESS) (time frame: Change from Baseline ESS at 1 month). The study lists 3 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 12 Nov 2020.