Sleep Apnea, ObstructiveNCT00901771
Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP
A study testing Provent in people with Sleep Apnea, Obstructive, run by St. Luke's Hospital, Chesterfield, Missouri at 1 site in United States.
Trial summary
The primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Provent
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current signs and symptoms consistent with a diagnosis of OSA in the opinion of the study physician
- Rejection of PAP treatment or minimally adherent with PAP treatment
- Use of the Provent device for a specified amount of time each night during three consecutive nights of the trial period
- AHI > 15, or AHI > 10 with evidence of CMS-recognized symptoms or co- morbidities, on screening/baseline PSG
- Investigator believes that subject can benefit from OSA treatment
- Subject understands and is willing and able to comply with study requirements
Who cannot join
- Use of any device that interferes with nasal or oral breathing
- Persistent blockage of one or both nostrils which prevents airflow in one or both nostrils
- Any chronic sores or lesions on the inside or outside of the nose
- Chronic use of nasal decongestants other than nasal steroids
- History of allergic reaction to acrylic-based adhesives (such as those found in BAND-AIDS®)
- Current acute upper respiratory (including nasal, sinus, or middle ear) inflammation or infection or perforation of the tympanic membrane (may be re-considered for participation after the acute episode resolves)
Show all 18Show fewer
- History of frequent and/or poorly treated severe nasal allergies or sinusitis which may interfere with the ability to use Provent
- Severe respiratory disorders (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum, etc.).
- Pathologically low blood pressure.
- Narcolepsy, idiopathic hypersomnolence, chronic insomnia, restless legs syndrome, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder other than OSA that could affect the likelihood of apneas/hypopneas during a PSG.
- Periodic limb movement arousal index (PLMAI) > 10 on the screening/baseline PSG.
- Current use of diurnal or nocturnal supplemental oxygen
- Currently working night or rotating shifts
- Consumption of > 10 caffeinated beverages per day (approximately 1000 mg per day)
- History of severe cardiovascular disease, including New York Heart Association Class III or IV heart failure, coronary artery disease with angina or myocardial infarction in the past 6 months, stroke in the past 6 months
- History of cardiac rhythm disturbance (defined as a 5-beat run of sustained ventricular tachycardia or bradycardia if < 30 beats per min for a 10-second run or previously undiagnosed and untreated atrial fibrillation or Mobitz II or third-degree heart block)
- Current psychiatric disorder with psychotic features.
- Pregnant or trying to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Medicine and Research Center at St. Luke's Hospital
Chesterfield, Missouri, 63017
About this study
Official title: A Non-randomized, Case Series Study of the Effectiveness of Provent Treatment of Obstructive Sleep Apnea Patients Who Are Non-compliant or Minimally Adherent With Positive Airway Pressure Therapy
The primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent) and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be assessed. A secondary objective is to assess adherence with Provent treatment during the 5-week evaluation period.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Provent
- Keywords
- Sleep, Sleep Apnea, Obstructive, OSA, OSAH
- 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.
ProventDevice
This is a non-randomized, single-arm, case series study. All subjects will receive Provent device.
What is being measured
The primary outcome is the main question the study is designed to answer.
Week 1 AHI as compared to Screening/Baseline AHI
Measured: 1 week
Secondary outcomes (3)
Week 5 AHI as compared to Screening/Baseline AHI
Measured: 5 weeks
Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline
Measured: 5 weeks
Epworth Sleepiness Scale: Week 5 vs. Baseline
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Chesterfield, Missouri
- Sponsor type
- University, hospital or other
- Collaborators
- Ventus Medical, Inc.
- Investigators
- James K Walsh, Ph.D., Principal investigator, Sleep Medicine and Research Center at St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901771
- Sponsor's protocol ID
- Ventus C020
- Status last verified
- Jun 2010
- First submitted
- 13 May 2009
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Case Series Study of the Effectiveness of Provent Treatment of Obstructive Sleep Apnea Patients Who Are Non-compliant or Minimally Adherent With Positive Airway Pressure Therapy
- ClinicalTrials.gov ID
- NCT00901771
- Acronym / sponsor ID
- Ventus C020
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep, Sleep Apnea, Obstructive, OSA, OSAH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Luke's Hospital, Chesterfield, MissouriUniversity, hospital or other
- Collaborators
- Ventus Medical, Inc.
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 May 2009 (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.
The primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent) and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be assessed. A secondary objective is to assess adherence with Provent treatment during the 5-week evaluation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current signs and symptoms consistent with a diagnosis of OSA in the opinion of the study physician
- Rejection of PAP treatment or minimally adherent with PAP treatment
- Use of the Provent device for a specified amount of time each night during three consecutive nights of the trial period
- AHI > 15, or AHI > 10 with evidence of CMS-recognized symptoms or co- morbidities, on screening/baseline PSG
- Investigator believes that subject can benefit from OSA treatment
Key exclusion criteria (18 listed)
- Use of any device that interferes with nasal or oral breathing
- Persistent blockage of one or both nostrils which prevents airflow in one or both nostrils
- Any chronic sores or lesions on the inside or outside of the nose
- Chronic use of nasal decongestants other than nasal steroids
- History of allergic reaction to acrylic-based adhesives (such as those found in BAND-AIDS®)
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 |
|---|---|---|
| ProventThis is a non-randomized, single-arm, case series study. All subjects will receive Provent device. | Device | – |
Primary outcome
Week 1 AHI as compared to Screening/Baseline AHI
Time frame: 1 week
3 secondary outcomes
Week 5 AHI as compared to Screening/Baseline AHI
Time frame: 5 weeks
Minutes with SaO2 <90%: Week 5 vs. Screening/Baseline
Time frame: 5 weeks
Epworth Sleepiness Scale: Week 5 vs. Baseline
Time frame: 5 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 15 Jun 2010.
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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.
James K Walsh, Ph.D. principal investigator
Sleep Medicine and Research Center at St. Luke's 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 Provent in people with Sleep Apnea, Obstructive, run by St. Luke's Hospital, Chesterfield, Missouri at 1 site in United States.
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 18 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 15 Jun 2010. 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 United States. 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?
Week 1 AHI as compared to Screening/Baseline AHI (time frame: 1 week). 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 15 Jun 2010; AzTrials last refreshed its copy on 7 Nov 2026.