NCT02614417

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

2.2 years

First QC Date

September 28, 2015

Last Update Submit

November 23, 2015

Conditions

Eisenmenger SyndromeCongenital Heart DiseaseSleep-disordered Breathing

Outcome Measures

Primary Outcomes (1)

  • Apnoea-hypopnoea index

    Prevalence of sleep-disordered breathing during 1 night polysomnography measured by apnoea-hypopnoea index.

    1 night on Day 1

Secondary Outcomes (1)

  • Sleep stages

    1 night on Day 1

Study Arms (1)

Polysomnography

Patients undergo an one-night in-hospital polysomnography to diagnose sleep-disordered breathing

Other: Polysomnography

Interventions

PolysomnographyOTHER

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.

Polysomnography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Eisenmenger syndrome

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Eisenmenger ComplexHeart Defects, CongenitalSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 28, 2015

First Posted

November 25, 2015

Study Start

June 1, 2013

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

November 25, 2015

Record last verified: 2015-11