Central Sleep Disordered Breathing, Sleep Apnea
Conditions
Brief summary
The aim of this post market study is to assess the impact of sleep-disordered breathing on the well-being of patients according to the treatment chosen, i.e. with or without implantation of the remedē® system to treat sleep-disordered breathing.
Detailed description
The sponsor of this study, LivaNova, has a partnership with Respicardia, Inc who has developed a battery-powered implantable device that treats central sleep apnea. The device is used with a lead that delivers the stimulation therapy which causes the patient to breathe with a regular rhythm and an optional lead that senses breathing. This combination is called the remedē® system. The aim of this study is 1. to collect data in order to get a better understanding of the characteristics and/or symptoms related to central sleep apnea 2. to collect safety information of all patients diagnosed with central sleep apnea 3. to obtain additional short and lang term information on the safety and performance of the remedē® system, including an evaluation if there's an impact on the quality of life of patients treated with the the remedē® system in daily practice. The information obtained from this study may provide better insight on the symptoms related to central sleep apnea, risk factors related to central sleep apnea therapy and use of the remedē® system which may help to treat other patients with potential sleep disordered breathing more appropriately. Approximately 300 patients (to be) implanted with the remedē® system will participate in this study at approximately 40 sites in Europe. For this purpose the investigators aim to screen approximately 1500 patients with sleep-disordered breathing. Also patients diagnosed with central sleep apnea, but not receiving the device will be followed through phone calls for 2 years.
Interventions
None listed
Sponsors
Respicardia, Inc.
LivaNova
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients screened for sleep disordered breathing * Age \> 18 years * Signed Ethics Committee approved informed consent Implant Inclusion criteria * Diagnosis of moderate to severe central sleep apnea and referred for implant of the remedē system / implanted with remedē system Implant
Exclusion criteria
* Patients meeting the criteria as referred to in the latest version of the implant manual
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | From implant up to 5 years (collected until 24 month FU) | Collect short and long term clinical data on safety of the remede system implanted in daily practice. This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline | 12 months post-implant | Evaluate changes in sleep study results at 12 months compared to baseline |
| Impact on Quality of Life Compared to Baseline | Up to 5 years post-implant | Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients |
| Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline | 12 months post implant | Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline |
| Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea | Up to 2 years (collected until 6M FU) | Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system |
Other
| Measure | Time frame | Description |
|---|---|---|
| Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea | screening | Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed. |
Countries
Germany, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CSA Patients NOT Implanted With remedē® System For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment. | 14 |
| CSA Patients With remedē System For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected. | 17 |
| Total | 31 |
Baseline characteristics
| Characteristic | CSA Patients With remedē System | Total | CSA Patients NOT Implanted With remedē® System |
|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 11.5 | 70.5 years STANDARD_DEVIATION 9.7 | 72.0 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment Germany | 16 participants | 28 participants | 12 participants |
| Region of Enrollment Spain | 1 participants | 3 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 15 Participants | 29 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 4 / 17 |
| serious Total, serious adverse events | 0 / 14 | 6 / 17 |
Outcome results
Primary
Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.
Collect short and long term clinical data on safety of the remede system implanted in daily practice. This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient.
Time frame: From implant up to 5 years (collected until 24 month FU)
Population: Viewing the limited amount of data at early study termination, the data should be interpreted with caution.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CSA Patients With remedē System | Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | Serious Adverse Events | 6 Participants |
| CSA Patients With remedē System | Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | Deaths | 0 Participants |
| CSA Patients With remedē System | Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | Serious Adverse Device Effects | 3 Participants |
| CSA Patients With remedē System | Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | Stimulation complaints | 1 Participants |
| CSA Patients With remedē System | Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years. | Cardiovascular events | 6 Participants |
Secondary
Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline
Evaluate changes in sleep study results at 12 months compared to baseline
Time frame: 12 months post-implant
Population: A complete dataset is only available for 1 patient and due to confidentiality reasons for this 1 patient we prefer not to present this data.
Secondary
Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline
Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline
Time frame: 12 months post implant
Population: No data available; no patient had completed a 12 months echo prior to the premature study stop
Secondary
Impact on Quality of Life Compared to Baseline
Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients
Time frame: Up to 5 years post-implant
Population: No data available on Quality of Life questionnaires; no patient completed the questionnaires at baseline AND at the 12M/24M follow-up at the time of premature study stop.
Secondary
Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea
Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system
Time frame: Up to 2 years (collected until 6M FU)
Population: No conclusion can be drawn on all-cause mortality and all-cause hospitalization rates for this group of patients;only 3 subjects diagnosed with CSA (not implanted) reached the 6M FU at the time of study termination. No deaths and/or hospitalizations had been reported in this subject group at the time of study termination.No 12M data is available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CSA Patients With remedē System | Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea | hospitalizations | 0 Participants |
| CSA Patients With remedē System | Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea | all cause mortality | 0 Participants |
Other Pre-specified
Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea
Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed.
Time frame: screening