SnoringPhase 1NCT00211627
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
A Phase 1 study testing KEEPASLEEP enhanced breathing device in people with Snoring and Sleep Apnea Syndromes, run by Miller, Chipp St. Kevin, M.D. at 1 site in United States.
Trial summary
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Snoring, Sleep Apnea Syndromes
- What is being tested?
- KEEPASLEEP enhanced breathing device
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2006
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally good health
- Intact dentition / ABSENT upper and lower wisdom teeth ( by extraction or lack of development )
- Simple snoring( documented by observer) or mild sleep apnea RDI < 15 ( documented by polysomnogram)
- Subject must have a concerned observer to assess of sleep and snoring behavior during trial period
- Exclusion Criteria:- Presence of Wisdom teeth (third molars)
- active oral disease
- acute illness
- BMI (body mass index) > 30
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Chipp St. Kevin Miller M.D.
Santa Monica, California, 90404
Chipp K. Miller, M.D., 310-829-7792, waycooldoc@aol.com
About this study
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.
Read the detailed description
The Keepasleep airway device is a novel and unique buccopharyngeal airway device to enhance breathing during sleep. This method has not been described in the medical literature and has been successful in limited testing. This clinical trial is to determine the safety and effectiveness of the KEEPASLEEP device utilizing 30 subjects with simple snoring. Each subject will serve as his/her own control. The device augments airflow into the posterior pharynx to minimize airway collapse,tissue vibration, and consequent snoring.The device passes through the retromaxillary space and requires that the subject be absent their wisdom teeth.
- Conditions
- Snoring, Sleep Apnea Syndromes
- Being tested
- KEEPASLEEP enhanced breathing device
- Medical subject headings
- Snoring, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KEEPASLEEP enhanced breathing deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction/Elimination of snoring behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Miller, Chipp St. Kevin, M.D.
- Sponsor type
- University, hospital or other
- Investigators
- Chipp K. Miller, M.D., Principal investigator, St. Johns Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211627
- Sponsor's protocol ID
- MILC - KEEPASLEEP - 0704
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.
- ClinicalTrials.gov ID
- NCT00211627
- Acronym / sponsor ID
- MILC - KEEPASLEEP - 0704
- Conditions
- Snoring, Sleep Apnea Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Miller, Chipp St. Kevin, M.D.University, hospital or other
- Study start
- Jun 2004
- Study completion
- Jun 2006
- First posted
- 21 Sep 2005 (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.
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.
Detailed description
The Keepasleep airway device is a novel and unique buccopharyngeal airway device to enhance breathing during sleep. This method has not been described in the medical literature and has been successful in limited testing. This clinical trial is to determine the safety and effectiveness of the KEEPASLEEP device utilizing 30 subjects with simple snoring. Each subject will serve as his/her own control. The device augments airflow into the posterior pharynx to minimize airway collapse,tissue vibration, and consequent snoring.The device passes through the retromaxillary space and requires that the subject be absent their wisdom teeth.
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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- generally good health
- Intact dentition / ABSENT upper and lower wisdom teeth ( by extraction or lack of development )
- Simple snoring( documented by observer) or mild sleep apnea RDI < 15 ( documented by polysomnogram)
- Subject must have a concerned observer to assess of sleep and snoring behavior during trial period
- Exclusion Criteria:- Presence of Wisdom teeth (third molars)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| KEEPASLEEP enhanced breathing device | Device | – |
Primary outcome
Reduction/Elimination of snoring behavior
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
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Prediction of Tongue Base Obstruction During Sleep
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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.
Chipp K. Miller, M.D. principal investigator
St. Johns Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KEEPASLEEP enhanced breathing device in people with Snoring and Sleep Apnea Syndromes, run by Miller, Chipp St. Kevin, M.D. 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 8 inclusion and 0 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 21 Sep 2005. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chipp K. Miller, M.D. (310 829-7792, waycooldoc@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction/Elimination of snoring behavior. 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 21 Sep 2005.