NCT04974515

Brief Summary

The purpose of this research is to assess how well people with mild obstructive sleep apnea (OSA) adhere to the eXciteOSA device and specifically examine whether adherence of the device is different with low versus high electrical stimulation. In addition, this research study will assess how well the device affects mild sleep apnea and if it improves sleepiness and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

July 13, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

August 17, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 16, 2023

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

July 13, 2021

Results QC Date

August 24, 2023

Last Update Submit

October 13, 2023

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Mean Number of Days Device Was Used

    Adherence level will be reported as the mean number of days the eXciteOSA device was used.

    Up to 6 weeks

Secondary Outcomes (8)

  • Mean Respiratory Event Index (REI)

    Up to 6 weeks

  • Epworth Sleepiness Scale (ESS) Scores

    Up to 6 weeks

  • Pittsburgh Sleep Quality Index (PSQI)

    Up to 6 weeks

  • Short Form-20 (SF-20) Scores

    Up to 6 weeks

  • Quality of Life as Measured by EuroQol Score

    Up to 6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Low intensity application of eXciteOSA

EXPERIMENTAL

Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks.

Device: eXciteOSA

High intensity application of eXciteOSA

ACTIVE COMPARATOR

Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks.

Device: eXciteOSA

Interventions

eXciteOSADEVICE

eXciteOSA is a device for improving genioglossus endurance through electrical stimulation

High intensity application of eXciteOSALow intensity application of eXciteOSA

Eligibility Criteria

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

You may qualify if:

  • Age greater than 18 years
  • Ability to consent
  • Home sleep apnea test demonstrating mild obstructive sleep apnea.
  • Smartphone or tablet

You may not qualify if:

  • Current pacemaker, defibrillator, or neuro-stimulation device
  • No prior oropharyngeal surgery for sleep apnea
  • No implants, metal prostheses, dental braces, or soft tissue/bony ulcerations in the oral cavity
  • No prior use of mandibular advancement device (MAD) or continuous positive airway pressure (CPAP)
  • Heart failure (New York Heart Association Class 3 or 4; or ejection fraction \< 45%)
  • Active coronary disease defined as an intervention (e.g., angioplasty, coronary artery bypass surgery) in the prior 6 months
  • Uncontrolled hypertension (BP \> 160/100)
  • Clinician diagnosis of any chronic lung disease except asthma
  • Chronic fatigue syndrome or fibromyalgia
  • Self-reported current illicit drug use in the past 30 days
  • Self-reported use of marijuana or opiates in the past 30 days
  • Use of supplemental oxygen
  • Self-reported use of prescribed or over the counter sleeping medications in the past 30 days
  • Current pregnancy or intention of becoming pregnant
  • Oropharyngeal abnormalities (class 2 or class 3 malocclusion)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Naresh M. Punjabi, MD, PhD
Organization
University of Miami, Miller School of Medicine
npunjabi@miami.edu
305-243-6388

Study Officials

  • Naresh Punjabi, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 23, 2021

Study Start

August 17, 2021

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

October 16, 2023

Results First Posted

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)