Obstructive Sleep ApneaNCT02324790
Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
A study testing iNAP® Sleep Therapy System in people with Obstructive Sleep Apnea, run by Somnics, Inc. at 4 sites in Taiwan.
Trial summary
This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- iNAP® Sleep Therapy System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesTaiwan
- Study dates
- Dec 2014to 13 Jan 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OSA, based on AHI 10~60 (as assessed per baseline PSG).
- Subject understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form.
- BMI ≦ 28.
Who cannot join
- Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
- Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the device. (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Sleep Therapy System.
- History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
- History of allergic reaction to silicone.
- Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
- Currently working nights, rotating night shifts, planned travel across four or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices.
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- Current use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study.
- Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including New York Heart Association (NYHA) class III or IV heart failure, CAD with angina or myocardial infarction (MI)/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the study.
- Female subjects who are pregnant or intend to become pregnant during the study period.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Mackay Memorial Hospital, Hsinchu
Hsinchu, 300
China Medical University Hospital
Taichung, 404
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)
This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
Read the detailed description
This is an open-lable, single-arm, evaluator-blind and prospective study aimed to evaluate the feasibility of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- iNAP® Sleep Therapy System
- Keywords
- OSA, Oral Pressure Therapy (OPT)
- 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.
iNAP® Sleep Therapy SystemDevice
Also called Negative Pressre Sleep Therapy System, iNAP®
The iNAP® Sleep Therapy System provides pressure gradient within the oral cavity to pull the tongue toward upper palate and the soft palate forward, which aims to maintain better upper airway patency near the pharynx to prevent sleep-disordered breathing.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treated with iNAP® Sleep Therapy System on the treatment PSG night. Receives: Device: iNAP® Sleep Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Apnea-Hypopnea Index (AHI)
The study was terminated. No enough samples for statistical analysis.
Measured: One treatment night
Secondary outcomes (3)
Change from baseline of obstructive apnea reduction
The study was terminated. No enough samples for statistical analysis.
Measured: One treatment night
Change from baseline of oxygen desaturation index (ODI)
The study was terminated. No enough samples for statistical analysis.
Measured: One treatment night
Adverse event (AE)/ serious adverse event (SAE) rate and type
During the entire study period, a total of only 9 events were reported by 8 patients.
Measured: From informed consent form obtained to the end of study, average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion13 Jan 2016
- Study completion13 Jan 2016
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somnics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- C.M. Lin, M.D., Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324790
- Sponsor's protocol ID
- CSP-1401-CIP
- Status last verified
- Mar 2018
- First submitted
- 11 Dec 2014
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT02324790
- Acronym / sponsor ID
- CSP-1401-CIP
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Oral Pressure Therapy (OPT)
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Somnics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- 13 Jan 2016 (actual)
- Study completion
- 13 Jan 2016 (actual)
- First posted
- 24 Dec 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.
This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
Detailed description
This is an open-lable, single-arm, evaluator-blind and prospective study aimed to evaluate the feasibility of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: iNAP® Sleep Therapy SystemTreated with iNAP® Sleep Therapy System on the treatment PSG night. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of OSA, based on AHI 10~60 (as assessed per baseline PSG).
- Subject understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form.
- BMI ≦ 28.
Key exclusion criteria (9 listed)
- Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
- Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the device. (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Sleep Therapy System.
- History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
- History of allergic reaction to silicone.
- Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
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 |
|---|---|---|
| iNAP® Sleep Therapy SystemAlso: Negative Pressre Sleep Therapy System, iNAP®The iNAP® Sleep Therapy System provides pressure gradient within the oral cavity to pull the tongue toward upper palate and the soft palate forward, which aims to maintain better upper airway patency near the pharynx to prevent sleep-disordered breathing. | Device | Treatment |
Primary outcome
Change from baseline of Apnea-Hypopnea Index (AHI)
Time frame: One treatment night
The study was terminated. No enough samples for statistical analysis.
3 secondary outcomes
Change from baseline of obstructive apnea reduction
Time frame: One treatment night
Change from baseline of oxygen desaturation index (ODI)
Time frame: One treatment night
Adverse event (AE)/ serious adverse event (SAE) rate and type
Time frame: From informed consent form obtained to the end of study, average of 4 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
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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.
C.M. Lin, M.D. principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iNAP® Sleep Therapy System in people with Obstructive Sleep Apnea, run by Somnics, Inc. at 4 sites 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early. Results are not available in the source record.
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?
Change from baseline of Apnea-Hypopnea Index (AHI) (time frame: One treatment night). 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 19 Mar 2018.