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Sleep-disordered Breathing in Eisenmenger Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02614417
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Information provided by (Responsible Party):
Cristel Sørensen, Rigshospitalet, Denmark

Brief Summary:
Sleep-disordered breathing (SDB) is a wellknown comorbidity in cardiovascular disease. Knowledge about SDB in adult congenital heart disease is limited.

Condition or disease Intervention/treatment
Eisenmenger Syndrome Congenital Heart Disease Sleep-disordered Breathing Other: Polysomnography

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Sleep-disordered Breathing in Eisenmenger Syndrome
Study Start Date : June 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients undergo an one-night in-hospital polysomnography to diagnose sleep-disordered breathing
Other: Polysomnography
One night polysomnography performed using standard techniques and scored in accordance with American Academy of Sleep Medicine standards. Polysomnography monitors sleep by electroencephalography (F4-A1, C4-M1, O2-M1 F3-M2, C3-M2, O1-A2), electro-myography (submental and tibialis anterior muscles), electro-oculography, nasal flow, respiratory effort, pulse oximetry and transcutaneous carbon dioxide partial pressure.

Primary Outcome Measures :
  1. Apnoea-hypopnoea index [ Time Frame: 1 night on Day 1 ]
    Prevalence of sleep-disordered breathing during 1 night polysomnography measured by apnoea-hypopnoea index.

Secondary Outcome Measures :
  1. Sleep stages [ Time Frame: 1 night on Day 1 ]
    Characterize the sleep architecture during 1 night polysomnography by evaluating the time spend in various sleep stages (N1, N2, N3, REM, measured by EEG)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Eisenmenger syndrome

Inclusion Criteria:

  • Eisenmenger Syndrome (definition: Pulmonary ≥ systemic vascular resistance with pulmonary-to-systemic shunt and cyanosis (periphery oxygen saturation < 92% at rest and/or < 87% during exercise).
  • Stable for ≥ 3 months (no hospitalization, no change of medication, no deterioration).

Exclusion Criteria:

  • Down's syndrome.
  • Iron deficiency (definition: Ferritin < 12 µg/l and/or transferring saturation < 20%).
  • Regular phlebotomy.
  • Suspicion of risk of non-compliance.

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Responsible Party: Cristel Sørensen, MD, Rigshospitalet, Denmark Identifier: NCT02614417     History of Changes
Other Study ID Numbers: 2012-01
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Apnea Syndromes
Heart Diseases
Eisenmenger Complex
Pathologic Processes
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities