NCT02878590

Brief Summary

Prospective, non-randomized, open label study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

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

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 19, 2018

Completed
Last Updated

February 19, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

August 22, 2016

Results QC Date

November 30, 2018

Last Update Submit

January 31, 2019

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Change in Apnea-Hypopnea Index (AHI)

    Obstructive Sleep Apnea (OSA) severity is divided into three categories based on the Apnea-Hypopnea Index (AHI) as follows: Mild (AHI of 5 to 15), Moderate (AHI of 15 to 30), and Severe (AHI \> 30). AHI is calculated by dividing the number of events (i.e. Apneas and hypopneas) by the number of hours of sleep. The primary outcome for the study was change in AHI, defined as the difference in AHI between the diagnostic PSG study (baseline with no device) and the final PSG study with the Bongo device for the subjects that completed the entire study.

    At Diagnostic Baseline PSG and at Final Treatment PSG with the device

Study Arms (1)

BONGO DEVICE

EXPERIMENTAL

All participants that qualify will receive the intervention of the Bongo device

Device: BONGO DEVICE

Interventions

BONGO DEVICEDEVICE

A device to be used for the treatment of mild to moderate obstructive sleep apnea

BONGO DEVICE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capacity and willingness to sign informed consent
  • ≥ 21 years of age
  • Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI ≤ 30) within 12 months of the screening visit with the 3% hypopnea criteria
  • Able to tolerate using the device during a day time trial/acclimation
  • Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)

You may not qualify if:

  • Nasal deformities
  • Severe nasal allergies
  • Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
  • Co-morbid sleep disorders
  • Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)
  • Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.
  • Full Face Mask user
  • Mouth breather
  • Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Center for Sleep Disorders

Alameda, California, 94501, 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
Javier Collazo
Organization
InnoMed Healthscience
jcollazo@innomedhs.com
9547739656

Study Officials

  • jerrold kram, MD

    California Center for Sleep Disorders

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

September 1, 2016

Primary Completion

November 30, 2017

Study Completion

November 30, 2017

Last Updated

February 19, 2019

Results First Posted

December 19, 2018

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)