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OpenTrials
Completed

NCT Number: NCT04950894

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Apnea+Hypopnea Apnea, Obstructive Apnea, Obstructive Sleep Dyssomnias Hypopnea, Sleep Nervous System Diseases OSA Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama At Birmingham, Birmingham, Alabama, United States

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About this study

All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit.

The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)

Safety and efficacy will be evaluated at Month 7, and again at Month 13.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Abbreviated: Additional criteria may apply:

Inclusion criteria

  • Diagnosis of moderate to severe OSA
  • Declines to use or does not tolerate PAP therapy

Exclusion criteria

  • Respiratory, cardiac, renal disease or other co-morbid conditions
  • BMI > 35 kg/m2
  • Specific PSG criteria outlined in the protocol

Treatment and study plan

Hypoglossal Nerve Stimulation

Device

Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)

Primary outcomes

  1. Rate of response to therapy when compared to no therapy for 6 months

    Time frame: Month 1 through Month 7

    The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7.

  2. Rate of all serious adverse device/procedure related events from time of implant through month 7

    Time frame: Month 1 through Month 7

    The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC).

Secondary outcomes

  1. Decrease in Oxygen Desaturation Index (Efficacy)

    Time frame: Baseline through Month 7

  2. Change in Functional Outcomes of Sleep Questionnaire (Efficacy

    Time frame: Baseline through Month 7

  3. Change in Epworth Sleepiness Scale (Efficacy)

    Time frame: Baseline through Month 7

  4. Change in EQ-5D (Efficacy)

    Time frame: Baseline through Month 7

  5. Change in PROMIS SDI/SRI (Efficacy)

    Time frame: Baseline through Month 7

  6. Change in SF-36 (Efficacy)

    Time frame: Baseline through Month 7

  7. Change in CGI-S/CGI-I (Efficacy)

    Time frame: Baseline through Month 7

  8. Descriptive analysis of all reported Adverse Events (Safety)

    Time frame: Consent through Month 7

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Acronym: OSPREY

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 6, 2021
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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