---
title: Chronic Evaluation of Respicardia Therapy
nct_id: NCT01124370
overall_status: COMPLETED
phase: PHASE2
sponsor: Respicardia, Inc.
study_type: INTERVENTIONAL
primary_condition: Sleep Disordered Breathing
countries: United States, Germany, Italy, Poland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01124370.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01124370"
ct_last_update_post_date: 2016-05-16
last_seen_at: "2026-05-12T07:04:47.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Chronic Evaluation of Respicardia Therapy

**Official Title:** Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea

**NCT ID:** [NCT01124370](https://clinicaltrials.gov/study/NCT01124370)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 57
- **Lead Sponsor:** Respicardia, Inc.
- **Conditions:** Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea, Central Sleep Apnea
- **Start Date:** 2010-05
- **Completion Date:** 2014-08
- **CT.gov Last Update:** 2016-05-16

## Brief Summary

The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.

The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study.

It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Candidate is at least 18 years old
* Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:

  * Apnea-Hypopnea Index (AHI) greater than or equal to 20 events/hr
  * Predominantly central origin (central apnea events comprise 50% or more of all apnea events)
  * Limited obstructive events (obstructive apneas comprise less than 20% of the AHI)

Exclusion Criteria:

* Candidates who are pregnant
* Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2
* Candidates with severe COPD
* Candidates with a history of cerebrovascular accident (CVA), myocardial infarction, coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to the study
* Candidates with unstable angina
* Candidates with history of primary pulmonary hypertension
```

## Arms

- **Treatment** (EXPERIMENTAL) — All enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation.

## Interventions

- **remedē (TM) system** (DEVICE) — Implantation of the remedē (TM) system, including implantable pulse generator, stimulation lead, and (optional) sensing lead. Nightly provision of unilateral transvenous phrenic nerve therapy during sleep periods.

## Primary Outcomes

- **AHI Change From Baseline at 3 Months** _(time frame: Baseline and 3 months on therapy)_ — Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.

## Secondary Outcomes

- **Related Adverse Events** _(time frame: Up to 2 years)_
- **Epworth Sleepiness Scale Change From Baseline at 6 Months** _(time frame: Baseline and 6 months on therapy)_
- **Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months** _(time frame: Baseline and 6 months on therapy)_
- **Heart Failure Clinical Composite** _(time frame: 6 months on therapy)_
- **Six-minute Hall Walk Test Change From Baseline at 6 Months** _(time frame: Baseline and 6 months on therapy)_
- **NYHA Functional Class Improvement From Baseline to 6 Months** _(time frame: Baseline and 6 months on therapy)_

## Locations (13)

- BryanLGH Heart Institute, Lincoln, Nebraska, United States
- The Ohio State University, Columbus, Ohio, United States
- Lancaster Heart and Stroke Foundation, Lancaster, Pennsylvania, United States
- St. Thomas Heart, Nashville, Tennessee, United States
- Sentara Cardiovascular Research Institute, Norfolk, Virginia, United States
- Heart and Diabetes Center, Bad Oeynhausen, Germany
- Köln University, Cologne, Germany
- University of Kiel, Kiel, Germany
- St. Adolf-Stift Hospital, Reinbek, Germany
- Policlinico di Monza-IRCCS, Monza, Italy
- Jagiellonian University, Krakow, Poland
- Medical Military Institute, Warsaw, Poland
- 4th Military Hospital, Wroclaw, Poland

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.bryanlgh heart institute|lincoln|nebraska|united states` — added _(2026-05-12)_
- `locations.the ohio state university|columbus|ohio|united states` — added _(2026-05-12)_
- `locations.lancaster heart and stroke foundation|lancaster|pennsylvania|united states` — added _(2026-05-12)_
- `locations.st. thomas heart|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.sentara cardiovascular research institute|norfolk|virginia|united states` — added _(2026-05-12)_
- `locations.heart and diabetes center|bad oeynhausen||germany` — added _(2026-05-12)_
- `locations.köln university|cologne||germany` — added _(2026-05-12)_
- `locations.university of kiel|kiel||germany` — added _(2026-05-12)_
- `locations.st. adolf-stift hospital|reinbek||germany` — added _(2026-05-12)_
- `locations.policlinico di monza-irccs|monza||italy` — added _(2026-05-12)_
- `locations.jagiellonian university|krakow||poland` — added _(2026-05-12)_
- `locations.medical military institute|warsaw||poland` — added _(2026-05-12)_
- `locations.4th military hospital|wroclaw||poland` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01124370*  
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