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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491828
• Other study ID #: 400
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2011
• Last updated: March 19, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: December 2011
• Source: Kai Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sleep Apnea
• Snoring

Intervention

Device:
• Kai Strap
Medical device component that vibrates on a subject's neck.

Locations

Country	Name	City	State
United States	Kai Medical Sleep Lab	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Kai Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Head, neck, or jaw movement	Movement of head, neck, or jaw as evidenced by manual observation and video camera.	1 month	No
Secondary	Affect of sleep stage	Electrocortical arousal caused by device as measured by EEG.	1 month	No