CompletedNot Applicable

Adaptive Servo-ventilation Monitoring Study

Germany40 participantsStarted 2014-05

Plain-language summary

Sleep disordered breathing is very common in patients with chronic heart failure with reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat sleep apnea in these patients. This is an observational study to document changes in respiratory parameters in HF patients using ASV for a period of 12 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: More than 18 years old Chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines NYHA Class III or IV at the time of inclusion with at least one hospitalization for heart failure in the last 12 months Moderate to severe sleep apnea (AHI ≥ 15/hour). Already using or willing to use ASV-therapy and able to tolerate the mask treatment Exclusion Criteria: Planned or scheduled heart valve interventions and/or CABG Untreated or therapy refractory Restless Leg Syndrome Patients for whom the use of positive airway pressure therapy may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation of hypoxemia, as measured by overnight pulse oximetery, with worsening heart failure

Timeframe: 12 months

Trial details

NCT IDNCT02133859

SponsorResMed

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Chronic Heart Failure trials