CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
AirSense™ 10 AutoSet +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02963597
NCT02963597N/ACompleted

Auto-PAP for Pulmonary Hypertension Treatment in Decompensated Heart Failure Patients With Obstructive Sleep Apnea: A Two Center Pilot Study

Albert Einstein Healthcare Network·interventional·Posted Nov 15, 2016·Updated Mar 30, 2020

In Brief

A clinical study evaluating AirSense™ 10 AutoSet and Standard Medical Therapy for Sleep Apnea, Obstructive and 2 related conditions. Completed, enrolled 21 participants across 2 sites in 2 countries.

Detailed Summary

The objective of the study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United States
CollaboratorsResmed Inc

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 15, 2016
Enrollment StartOct 1, 2016
Primary CompletionAug 1, 2017
Study CompletionAug 15, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.6 years ago

Interventions

AirSense™ 10 AutoSetdevice

The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.

Standard Medical Therapyother

Standard medical therapy according to current guidelines.