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OpenTrials
Active, Not Recruiting

NCT Number: NCT03884660

remedē System Therapy Study

The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Central Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLVG Amsterdam, Amsterdam, Netherlands

Loading trial locations.

About this study

This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē System. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe. A sub-study involving the WatchPAT device will be performed in a subset of sites.

Who can participate

Healthy volunteers accepted: No

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

  • Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is strongly recommended that a patient have a diagnostic PSG within 12 months of the expected implant date documenting moderate to severe CSA.
  • Age 18 years or older
  • Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent
  • In the opinion of the investigator, subject is willing and able to comply with the protocol.
  • Not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
  • In the opinion of the Investigator, life expectancy exceeds one year.
  • The subject is not pregnant or planning to become pregnant.

Treatment and study plan

remede System

Device

Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.

Primary outcomes

  1. Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy

    Time frame: 5 years

    Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy

  2. Evaluate changes in sleep disordered breathing metrics after 12 months of therapy

    Time frame: 12 months

    Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4) and percent of sleep with oxygen saturation <90%

Secondary outcomes

  1. Evaluate safety of the remedē System by assessment of non-serious AE related to procedure, device or delivered therapy

    Time frame: 5 years

    Proportion of subjects with non-serious AEs related to the remedē System implant procedure, device or delivered therapy

  2. Evaluate changes in sleep disordered breathing metrics after 36 and 60 months of therapy

    Time frame: 36 and 60 months

    Change from baseline to 36- and 60-month visits for the following sleep metrics during an at home sleep apnea test (HSAT): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4), percent of sleep with oxygen saturation <90%

Other outcomes

  1. Evaluate changes in daytime sleepiness through 12 months

    Time frame: 12 months

    Epworth Sleepiness Scale (ESS) change from baseline to 12-month visit

  2. Evaluate changed in quality of life (QOL) through 12 months

    Time frame: 12 months

    Quality of life assessment including the following:

    • Kansas City Cardiomyopathy Questionnaire (KCCQ) change from baseline at 12 months (HF subgroup only)
    • PROMIS-29 questionnaire change from baseline at 12, months
    • Patient Global Assessment (PGA) at 12 months

  3. Evaluate changes in left ventricular ejection fraction in the HF subgroup after 12 months of therapy

    Time frame: 12 months

    Change in left ventricular ejection fraction based on echocardiographic assessment in the HF subgroup from baseline to 12 months.

Sponsors and collaborators

Lead sponsor

Respicardia, Inc.

Industry

Registry information

Official study title

Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System

Acronym: rēST

Important dates

Study start
2019
Primary completion
2026
Study completion
2030
First posted
Mar 21, 2019
Registry last updated
Jul 24, 2025

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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