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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025989
Enrollment
20
Registered
2022-01-05
Start date
2021-07-30
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Fontan circulation

Interventions

Group 1: During the study, patients with a fontane circulation are reduced to approximately 15.2% oxygen in the ambient air for about 24 to 36 hours, which results in an altitude exposure of approx. 2

Sponsors

Abteilung für Kinderkardiologie des Universitätsklinikums Bonn
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 30 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The main objectives of the sleep study are: 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%. 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. 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.

Countries

Germany

Contacts

Public ContactNicole Müller

Abteilung für Kinderkardiologie des Universtätsklinikums Bonn

nicole-mueller@ukb.uni-bonn.de0228-287-33350

Outcome results

None listed

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