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Completed

NCT Number: NCT01491828

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

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

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kai Medical Sleep Lab

Honolulu, Hawaii, 96816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kai Strap

Device

Medical device component that vibrates on a subject's neck.

Other names: Kai Patch

Primary outcomes

  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 outcomes

  1. Affect of sleep stage

    Time frame: 1 month

    Electrocortical arousal caused by device as measured by EEG.

Sponsors and collaborators

Lead sponsor

Kai Medical, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 14, 2011
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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