Effects of Nasal-High Flow therapy on obstructive sleep apnoea and autonomic nervous system function in patients with pulmonary-arterial hypertensio

• Conditions: G47.31; I27.0; Primary pulmonary hypertension

• Registration Number: DRKS00013907
• Lead Sponsor: Department für Neurologie - Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-06
• Study Completion: 2019-05-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

a. Age > 18 years (no age limit)
b. able to consent
c. Diagnosis of Nizza class I pumonary arterial Hypertension -PAH- according to the most recent Guidelines of the European Society of Cardiology (ESC); >12 weeks since the diagnosis of PAH has been made; no hospitalisation for HF in the last 4 weeks; optimal medical therapy in accordance with the most recent Guidelines of the European Society of Cardiology (ESC) with no change in medication in the last 4 weeks and combination for PAH -where there was no treatment with combination therapy in PAH patients then the reason must be documented-
d. Presence of at least moderate obstructive sleep apnea
e. Adequate tolerance of nasal mask based cPAP treatment of OSA

Exclusion Criteria

- secondary (postcapillary) pulmonary hypertension (mean pulmonary arterial hypertension > 25 mmHg; PCWP >15 mmHg)
-COPD
- other severe internistic pre-existing conditions, especially insulin-dependent diabetes or severe renal impairment
- severe neurological pre-existing conditions such as stroke, especially brainstem infarction
- intake of opioids
- severe psychiatric pre-existing conditions

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean heart rate [bpm], high frequency component of heart rate variability [%], low frequency component of diastolic blood pressure variability [%]

Secondary Outcome Measures

Name	Time	Method
Apnoea-Hypopnoea-Index [/h], Hypopnoea-Index [/h], obstructive Apnoea-Index [/h], cycle lengths of obstructive events [sec], Systolic blood pressure [mmHG], diastolic blood pressure [mmHG], stroke volume index [L/min/m²], high frequency component of diastolic blood pressure variability[%], low frequency component of heart rate variability [%], respiratory rate [/min], tidal volume [ml], minute ventilation [L/min], oxygen saturation [%], transcutaneous CO2 [mmHG], sleep stage Non-Rem I [%], sleep stage Non-Rem II [%], sleep stage Non-Rem III [%], sleep stage REM [%], Awake [%], Arousal Index [/h]