NCT05018234

Brief Summary

The purpose of this study is to evaluate the safety profile of the novel oral appliance (OA )device and to assess patient comfort of the novel OA device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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

August 4, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

August 18, 2021

Last Update Submit

May 24, 2022

Conditions

Obstructive Sleep Apnea

Keywords

oral appliancesleep apneahypoxia

Outcome Measures

Primary Outcomes (1)

  • safety of device as measured by the number of patients with adverse events

    During the time the OA device is worn, that is, from the time of appointment 2(1 month after enrollment) to the time of appointment 3 (1 week after appointment 2)"

Secondary Outcomes (2)

  • Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey

    1 month after enrollment(appointment 2)

  • Comfort of the novel OA device as measured by the post care patient feedback survey

    1 week after appointment 2(appointment 3)

Study Arms (1)

Treatment

EXPERIMENTAL
Device: Noval Oral Appliance

Interventions

Noval Oral ApplianceDEVICE

A scan of the mouth will be performed to make the oral device. The device will be 3D printed with Asiga UV Max printer using FDA 510(k) cleared VeriSplint OS Resin.Subjects will be will be asked to wear the oral device at night for 3 nights and fill out a survey reviewing their experience wearing the device.

Treatment

Eligibility Criteria

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

You may qualify if:

  • No history of obstructive sleep apnea
  • No active jaw joint pain
  • No active moderate to severe periodontal disease
  • Presence of 12 teeth per arch

You may not qualify if:

  • presence of severe bruxism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea SyndromesHypoxia

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aaron Glick, DDS

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 18, 2021

First Posted

August 24, 2021

Study Start

August 4, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)