Sleep ApneaPhase 1NCT01491828
Study to Determine Results of Vibratory Stimulus on Subject's Neck
A Phase 1 study testing Kai Strap in people with Sleep Apnea and Snoring, run by Kai Medical, Inc. at 1 site in United States.
Trial summary
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Snoring
- What is being tested?
- Kai Strap
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2012
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, ages 18 to 80 years old
- Able to provide written informed consent for themselves and comply with study procedures.
Who cannot join
- Known hyposensitivity or hypersensitivity to vibrations on neck.
- Neurological disorder such as seizure disorder or narcolepsy.
- Psychiatric disorders currently not under control.
- Insomniacs.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.
Read the detailed description
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement, and provide information regarding the optimum location and variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck, or jaw movement. The study will also provide information whether the subject experienced or did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's neck. The data gathered from this study will be used for future studies in analyzing whether such vibratory stimulus can serve as a potential treatment for sleep disorders, such as snoring and obstructive sleep apnea.
- Conditions
- Sleep Apnea, Snoring
- Being tested
- Kai Strap
- Keywords
- Apnea, Sleep apnea, Snoring, Hypoglossal nerve stimulation, Laynx stimulation
- Medical subject headings
- Sleep Apnea Syndromes, Snoring, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kai StrapDevice
Also called Kai Patch
Medical device component that vibrates on a subject's neck.
What is being measured
The primary outcome is the main question the study is designed to answer.
Head, neck, or jaw movement
Movement of head, neck, or jaw as evidenced by manual observation and video camera.
Measured: 1 month
Secondary outcomes (1)
Affect of sleep stage
Electrocortical arousal caused by device as measured by EEG.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelley Ford Shippey III, MD, MS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491828
- Sponsor's protocol ID
- 400
- Status last verified
- Dec 2011
- First submitted
- 10 Dec 2011
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine Results of Vibratory Stimulus on Subject's Neck
- ClinicalTrials.gov ID
- NCT01491828
- Acronym / sponsor ID
- 400
- Conditions
- Sleep Apnea, Snoring
- Keywords
- Apnea, Sleep apnea, Snoring, Hypoglossal nerve stimulation, Laynx stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kai Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Dec 2011 (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 study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.
Detailed description
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement, and provide information regarding the optimum location and variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck, or jaw movement. The study will also provide information whether the subject experienced or did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's neck. The data gathered from this study will be used for future studies in analyzing whether such vibratory stimulus can serve as a potential treatment for sleep disorders, such as snoring and obstructive sleep apnea.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, ages 18 to 80 years old
- Able to provide written informed consent for themselves and comply with study procedures.
Key exclusion criteria (5 listed)
- Known hyposensitivity or hypersensitivity to vibrations on neck.
- Neurological disorder such as seizure disorder or narcolepsy.
- Psychiatric disorders currently not under control.
- Insomniacs.
- Pregnant women.
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 |
|---|---|---|
| Kai StrapAlso: Kai PatchMedical device component that vibrates on a subject's neck. | Device | – |
Primary outcome
Head, neck, or jaw movement
Time frame: 1 month
Movement of head, neck, or jaw as evidenced by manual observation and video camera.
1 secondary outcome
Affect of sleep stage
Time frame: 1 month
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 20 Mar 2012.
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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.
Kelley Ford Shippey III, MD, MS principal investigator
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 Kai Strap in people with Sleep Apnea and Snoring, run by Kai Medical, Inc. 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 2 inclusion and 5 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 20 Mar 2012. 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?
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?
Head, neck, or jaw movement (time frame: 1 month). 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 20 Mar 2012.