Effect of medium-term, moderate hypoxia on sleep patterns, pulmonary blood flow, hemorheology, and exercise capacity in patients with Fontan circulation.

Recruiting

Conditions: Fontan circulation

Registration Number: DRKS00025989

Lead Sponsor: Abteilung für Kinderkardiologie des Universitätsklinikums Bonn

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Hemodynamically stable Fontan patients (10 w; 10 m).
- Age 16 to 30 years
- Peripheral saustoff saturation = 90%.
- Physical and mental ability to complete spiroergometry on a bicycle ergometer
- Signed informed consent (If underage, also signed informed consent from both parents).

Exclusion Criteria

- Failing Fontan (protein-losing enteropathy, ascites, bronchitis plastica, NYHA stage III or IV).
- Fenestration in the Fontan tunnel
- Peripheral oxygen saturation < 90 % in normoxia
- Stent in pulmonary artery, Glenn anastomosis and/or proximal tunnel of Fontan
- Claustrophobia
- smoker
- Obesity (BMI = 30)
- Cardiac pacemaker
- Acute infections
- Medication with sildenafil or bosentan
- Medication with hypnotics
- Known sleep disorders
- Known depression, previous psychiatric illnesses

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main objectives of the sleep study are:<br><br>1. to determine the minimum nocturnal value of peripheral oxygen saturation and the proportion of sleep time spent during which oxygen saturation falls below 85%.<br>2. polysomnographic recording of sleep in Fontan patients under moderate normobaric hypoxia exposure. In particular, the sleep efficiency and the proportion of different sleep stages and waking phases will be determined.<br>3. to collect first normative data for Fontan patients, which will then be compared with data from preliminary studies of healthy control subjects under hypoxia.<br><br><br>

Secondary Outcome Measures