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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kai Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01491828
First received: December 10, 2011
Last updated: March 19, 2012
Last verified: December 2011
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study to Determine Results of Vibratory Stimulus on Subject's Neck

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Snoring
U.S. FDA Resources

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

Primary Outcome Measures:
  • Head, neck, or jaw movement [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kai Medical, Inc.
ClinicalTrials.gov Identifier: NCT01491828     History of Changes
Other Study ID Numbers: 400
Study First Received: December 10, 2011
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013