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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013907
Enrollment
13
Registered
2018-08-06
Start date
2018-08-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G47.31 I27.0

Interventions

Group 1: After the diagnosis of OSA has been made and cPAP treatment has been initiatied in 13 OSA patients with PAH, patients will spend a third night in our university sleep lab. Therein, patients w

Sponsors

Department für Neurologie - Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Mean heart rate [bpm], high frequency component of heart rate variability [%], low frequency component of diastolic blood pressure variability [%]

Secondary

MeasureTime frame
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]

Countries

Germany

Contacts

Public ContactMatthias Boentert

Department für Neurologie- Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster

matthias.boentert@ukmuenster.de00492518344458

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026