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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491828
First Posted: December 14, 2011
Last Update Posted: March 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kai Medical, Inc.
  Purpose
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

Condition Intervention Phase
Sleep Apnea Snoring Device: Kai Strap Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study to Determine Results of Vibratory Stimulus on Subject's Neck

Further study details as provided by Kai Medical, Inc.:

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


Estimated Enrollment: 100
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Kai Strap
    Medical device component that vibrates on a subject's neck.
    Other Name: Kai Patch
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Kai Medical, Inc.
ClinicalTrials.gov Identifier: NCT01491828     History of Changes
Other Study ID Numbers: 400
First Submitted: December 10, 2011
First Posted: December 14, 2011
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