Health TrialsbyHealthPanel

Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation

ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorNyxoah Inc.

About this trial

The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio® System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have an apnea-hypopnea index (AHI) greater than or equal to 15 and less than or equal to 65, measured on a full-night PSG performed no earlier than 2 years prior to enrollment (AHI4 and ODI4 available).

Be adults 22 years of age and older.

Have been confirmed to have failed, not tolerated, or be ineligible to be treated with current standard of care treatments for moderate to severe OSA.

Have pursued insurance pre-authorization for Genio® Therapy, recognizing that pre-authorization does not ensure payment, or demonstrate willingness to assume any out-of-pocket costs. The sponsor will not be responsible for treatment-related charges.

Disqualifiers

Combined central and mixed apnea-hypopnea index (AHI) greater than or equal to 25% of the total AHI.

Any functional or structural problem, medical illness or condition that would prevent or interfere with implantation, activation or continued use of the Genio® Therapy.

Have an implantable device which may be susceptible to unintended interaction with the Genio® System 2.1.

Women who are pregnant, planning to become pregnant or breastfeeding.

Trial population

Subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1

    Device

    Genio® System 2.1

Treatment groups

229 Participants
are divided into 1 treatment group
Group A: Genio System 2.11 intervention

Trial outcomes

Primary outcomes

1

Change in Apnea Hypopnea Index (AHI4%)

Percentage of responders at 12 months based on AHI4

Time frame
12 months
2

Change in Oxyhemoglobin Desaturation Index (ODI4%)

Percentage of responders at 12 months based on ODI4

Time frame
12 months
3

Device related SAEs

Incidence of device-related Serious Adverse Events at 12 months post-surgery

Time frame
12 months
4

Device-related and procedure-related SAEs

Incidence of device-related and procedure-related SAEs at 12 months post-surgery

Time frame
12 months

Secondary outcomes

1

Mean change in AHI4

Mean change in AHI4 from screening to 12, 24, 36, 48, and 60 months post-surgery.

Time frame
Baseline to 5 years
2

Mean change in ODI4

Mean change in ODI4 from screening to 12, 24, 36, 48, and 60 months post-surgery.

Time frame
Baseline to 5 years
3

% responders AHI4

Percentage of responders at 24, 36, 48, and 60 months based on AHI4 according to "Sher criteria".

Time frame
2 years through 5 years
4

% responders ODI4

Percentage of responders at 24, 36, 48 and 60 months based on ODI4

Time frame
2 years through 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nyxoah Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now