Trial Outcomes & Findings for Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry (NCT NCT01500759)

NCT ID: NCT01500759

Last Updated: 2020-07-09

Results Overview

SDB= Sleep disordered breathing; HF= Heart failure

• Recruitment status: COMPLETED
• Target enrollment: 6876 participants
• Primary outcome timeframe: 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility
• Results posted on: 2020-07-09

Participant Flow

Participant milestones

Measure	Chronic HF Without SDB Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Overall Study STARTED	3686	3190
Overall Study COMPLETED	3686	3190
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry

Baseline characteristics by cohort

Measure	Chronic HF Without SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and no sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Total n=6876 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 12 • n=93 Participants	69 years STANDARD_DEVIATION 11 • n=4 Participants	67 years STANDARD_DEVIATION 11.5 • n=27 Participants
Sex: Female, Male Female	932 Participants n=93 Participants	516 Participants n=4 Participants	1448 Participants n=27 Participants
Sex: Female, Male Male	2754 Participants n=93 Participants	2674 Participants n=4 Participants	5428 Participants n=27 Participants

PRIMARY outcome

Timeframe: 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for sleep-disordered breathing during 1 night in a sleep facility

SDB= Sleep disordered breathing; HF= Heart failure

Outcome measures

Measure	Chronic HF With SDB n=6876 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Prevalence of SDB in Chronic HF Patients	3190 Participants	—

SECONDARY outcome

Timeframe: 1 night: Patients fulfilling the inclusion and exclusion criteria were examined for LVEF in a medical institution

Amount of blood in the left ventricle at the end of Diastole that is being pumped into the System during systole

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Left Ventricular Ejection Fraction	33.6 % ejection fraction Standard Deviation 8.0	32.8 % ejection fraction Standard Deviation 8.3

SECONDARY outcome

Timeframe: 1-time single assessment at baseline

Age years

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Age	65 years Standard Deviation 12	69 years Standard Deviation 11

SECONDARY outcome

Timeframe: 1-time single assessment at baseline

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Body Mass Index	28.1 kg/m˄2 Standard Deviation 5.0	28.9 kg/m˄2 Standard Deviation 5.2

SECONDARY outcome

Timeframe: 1-time single assessment at baseline

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Male Gender	2754 Participants	2674 Participants

SECONDARY outcome

Timeframe: At baseline, the NYHA was determined in a medical institution or taken restrospectively from medical records

New York Heart Association Class III: Marked Limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue or palpitations.

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
NYHA Class ≥III	2566 Participants	2341 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline the ischemic etiology was determined in the medical institution or taken retrospectively from the medical records.

Ischemic etiology describes a condition where a weakening or disease of the heart muscle is caused by reduced supply of blood (underlying cause might be the coronary artery). Secondary outcome ischemic etiology describes the cause of heart failure (HF) "ischemic" in HF patients without and with sleep-disordered breathing in percent of the respective study arm/group: e.g. x% of patients without SDB have HF with an ischemic etiology.

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Ischemic Etiology	1961 Participants	1742 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline atrial fibrillation (AF) was determined in the medical institution or AF history was taken retrospectively from the medical records

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Atrial Fibrillation	863 Participants	1001 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline history of nocturnal dyspnea taken retrospectively from the medical records

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Nocturnal Dyspnea	672 Participants	800 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline nocturia was assessed 1 time (anamnesis)

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Nocturia ≥3 Times/Night	580 Participants	660 Participants

SECONDARY outcome

Timeframe: 1 night: Apnoea-Hypopnea Index (AHI) was assessed during one night under polysomnography (PSG) in a sleep facility

Number of Apnoeas (cessation of airflow for at least 10 seconds) and hypopneas (reduced airflow for at least 10 seconds) per hours of sleep

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Apnoea-Hypopnea-Index	6 events/hour Standard Deviation 4	31 events/hour Standard Deviation 14

SECONDARY outcome

Timeframe: 1 time: Oxygen desaturation Index (ODI) was assessed during one night under polysomnography (PSG) in a sleep facility

Number of times that arterial blood oxygen saturation Drops by ≥3% from the Basic value.

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Oxygen Desaturation Index	8 events/hour Standard Deviation 10	24 events/hour Standard Deviation 15

SECONDARY outcome

Timeframe: 1 night: oxygen saturation was assessed during one night under polysomnography (PSG) in a sleep facility

Saturation of oxygen

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Mean SpO2	93 %oxygen saturation Standard Deviation 2	92 %oxygen saturation Standard Deviation 3

SECONDARY outcome

Timeframe: 1 night: Minimum saturation with oxygen was assessed during one night under polysomnography (PSG) in a sleep facility

Lowest Saturation with oxygen

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Min SpO2	83 % oxygen saturation Standard Deviation 6	80 % oxygen saturation Standard Deviation 6

SECONDARY outcome

Timeframe: 1-time: At baseline medication was assessed 1 time (anamnesis)

ACE: Angiotensin converting Enzyme; ARB Angiotension receptor blocker

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Medication ACE Inhibitors and/ARBs	3269 Participants	2812 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline medication was assessed 1 time (anamnesis)

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Beta-blocker	3284 Participants	2824 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline medication was assessed 1 time (anamnesis)

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Diuretics	2805 Participants	2617 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline medication was assessed 1 time (anamnesis)

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Digitalis	717 Participants	599 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline medication was assessed 1 time (anamnesis)

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Aldosterone Antagonists	1808 Participants	1454 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

From the total number of participants, the number of male patients without and with SDB were counted and an odds Ratio for male sex as predictor for SDB in chronic heart failure

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Male Gender as Predictor for SDB in Chronic HF	2754 Participants	2674 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for AF as predictor for SDB in chronic heart failure

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Atrial Fibrillation (AF) as a Predictor for SDB in Chronic HF	863 Participants	1001 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for ischemic etiology as predictor for SDB in chronic heart failure

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
Ischemic Etiology as Predictor for SDB in Chronic HF	1961 Participants	1742 Participants

SECONDARY outcome

Timeframe: 1-time: At baseline physical status was assessed 1 time (anamnesis and medical records)

From the total number of participants, the number of male patients without and with SDB were counted and an odds ratio calculated for NYHA (New York Heart Association - class I not impaired, class II slighly impaired, class III severly impaired, class IV = unable to perform normal tasks) class≥III as predictor for SDB in chronic heart failure

Outcome measures

Measure	Chronic HF With SDB n=3686 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)	Chronic HF With SDB n=3190 Participants Patients with chronic heart failure (left ventricular ejection fraction ≤45% or New York Heart Association (NYHA) class III or IV or NYHA class II with ≥1 hospitalization within 12 months before inclusion) and sleep disordered breathing (SDB, Apnoea-Hypopnoea Index AHI ≥15)
NYHA Class >= III as Predictor for SDB in Chronic HF	2566 Participants	2341 Participants

Adverse Events

Chronic HF Without SDB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chronic HF With SDB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Affairs CRS

ResMed Germany Inc

Phone: 089990100

Email: ClinicalResearch&Strategy@ResMed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place