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Study to Determine Results of Vibratory Stimulus on Subject's Neck

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ClinicalTrials.gov Identifier: NCT01491828
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):
Kai Medical, Inc.

Brief Summary:
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

Condition or disease Intervention/treatment Phase
Sleep Apnea Snoring Device: Kai Strap Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study to Determine Results of Vibratory Stimulus on Subject's Neck
Study Start Date : November 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Intervention Details:
    Device: Kai Strap
    Medical device component that vibrates on a subject's neck.
    Other Name: Kai Patch


Primary Outcome Measures :
  1. Head, neck, or jaw movement [ Time Frame: 1 month ]
    Movement of head, neck, or jaw as evidenced by manual observation and video camera.


Secondary Outcome Measures :
  1. Affect of sleep stage [ Time Frame: 1 month ]
    Electrocortical arousal caused by device as measured by EEG.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, ages 18 to 80 years old
  • Able to provide written informed consent for themselves and comply with study procedures.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491828


Locations
United States, Hawaii
Kai Medical Sleep Lab
Honolulu, Hawaii, United States, 96816
Sponsors and Collaborators
Kai Medical, Inc.
Investigators
Principal Investigator: Kelley Ford Shippey III, MD, MS

Responsible Party: Kai Medical, Inc.
ClinicalTrials.gov Identifier: NCT01491828     History of Changes
Other Study ID Numbers: 400
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: December 2011

Keywords provided by Kai Medical, Inc.:
Apnea
Sleep apnea
Snoring
Hypoglossal nerve stimulation
Laynx stimulation

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Snoring
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms