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BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse (BETTER SLEEP)

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ClinicalTrials.gov Identifier: NCT03763682
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Nyxoah S.A.

Brief Summary:
The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Genio(TM) bilateral hypoglossal nerve stimulation system Not Applicable

Detailed Description:
This is a prospective, open-label, multicentric, 2 groups study to assess the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate. Participants will be consented, enrolled and eligibility criteria checked. If the participant is eligible, participant will proceed with the Genio™ IS implantation. Six (6) weeks after implantation, the implant will be activated and study visits will be scheduled at Week 7, Month 2, Month 3, Month 4, Month 5 and Month 6.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, open-label, 2 groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Prospective, Open-label, 2 Groups Study to Assess the Safety and Performance of the Genio™ Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea in Adult Patients With and Without Complete Concentric Collapse of the Soft Palate
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Sleep Apnea

Arm Intervention/treatment
Experimental: Genio(TM) system therapy
Genio(TM) bilateral hypoglossal nerve stimulation system
Device: Genio(TM) bilateral hypoglossal nerve stimulation system
Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation




Primary Outcome Measures :
  1. Incidence of serious device-related adverse events recorded during the study [ Time Frame: 6 months ]
  2. Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI) [ Time Frame: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI) ]

Secondary Outcome Measures :
  1. Change from baseline to 6 months post implantation in Oxygen Desaturation Index (ODI) [ Time Frame: 6 moinths ]
  2. Therapy response rate [ Time Frame: 6 months ]
    Response is defined as a reduction in AHI from baseline to 6 months of 50% or higher and apnoea-hypopnea index (AHI) at 6 months less than 20.

  3. Change from baseline to 6 months post implantation in daytime sleepiness measured with Epworth Sleepiness Scale (ESS) [ Time Frame: 6 months ]
    The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought. A reduction in ESS is considered a better outcome with a decrease of 2 points considered to be clinically significant.

  4. Sleep-related quality of life, measured by functional Outcomes of Sleep Questionnaire (FOSQ-10) score [ Time Frame: 6 months ]
    The questionnaire assesses the impact of excessive sleepiness on functional outcomes relevant to daily behaviors and sleep-related quality of life. It uses a 4-point Likert response format (1= extreme difficulty to 4=no difficulty) for 5 subscales: 1) activity level (3 items), 2) vigilance(3 items), 3) intimacy and sexual relationships (1 item), 4) general productivity (2 items), and 5) social outcomes (1 item). A total score is calculated and an increase is considered an improvement.

  5. Change from baseline to 6 months post implantation in snoring intensity [ Time Frame: 6 months ]
    Measured subjectively by the bed partner using a 5 point scale of no scoring, light snoring, medium snoring, very loud snoring, to leaving the bedroom.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Man or woman between 21 and 75 years of age
  • Body mass index (BMI) ≤ 32 kg/m2
  • Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
  • Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.

Exclusion Criteria:

  • Unable or incapable of providing informed written consent
  • Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763682


Contacts
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Contact: Charles Czank, PhD clinical@nyxoah.com
Contact: William Johnston clinical@nyxoah.com

Locations
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Australia, New South Wales
Westmead Private Hospital Not yet recruiting
Westmead, New South Wales, Australia, 2145
Contact: John Wheatley, MBBS         
Wollongong Private Hospital Not yet recruiting
Wollongong, New South Wales, Australia, 2500
Contact: Stuart Mackay, MBBS         
Australia, Victoria
Institute Breathing and Sleep Austin Hospital Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Maree Barnes, MBBS         
Australia, Western Australia
Hollywood Hospital Recruiting
Nedlands, Western Australia, Australia, 6005
Contact: Richard Lewis, MBBS         
Sponsors and Collaborators
Nyxoah S.A.

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Responsible Party: Nyxoah S.A.
ClinicalTrials.gov Identifier: NCT03763682     History of Changes
Other Study ID Numbers: BETTER SLEEP
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases