NCT01491828

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 20, 2012

Status Verified

December 1, 2011

Enrollment Period

2 months

First QC Date

December 10, 2011

Last Update Submit

March 19, 2012

Conditions

Sleep ApneaSnoring

Keywords

ApneaSleep apneaSnoringHypoglossal nerve stimulationLaynx stimulation

Outcome Measures

Primary Outcomes (1)

  • Head, neck, or jaw movement

    Movement of head, neck, or jaw as evidenced by manual observation and video camera.

    1 month

Secondary Outcomes (1)

  • Affect of sleep stage

    1 month

Interventions

Kai StrapDEVICE

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

Also known as: Kai Patch

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kai Medical Sleep Lab

Honolulu, Hawaii, 96816, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSnoringApnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kelley Ford Shippey III, MD, MS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2011

First Posted

December 14, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 20, 2012

Record last verified: 2011-12

Locations

US(1)