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Long QT Syndrome and Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03678311
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
MetroHealth Medical Center
Information provided by (Responsible Party):
Reena Mehra, MD, The Cleveland Clinic

Brief Summary:
Obstructive sleep apnea (OSA) has been associated with cardiac repolarization abnormalities and implicated in sudden cardiac death. A biologically plausible mechanism by which OSA exerts this lethality is by QT interval prolongation, a known marker of ventricular tachyarrhythmias (VTA) leading to cardiac death. Congenital long QT syndrome (LQTS) is a familial arrhythmogenic disorder characterized by prolonged QT interval on the electrocardiogram and increased propensity for VTA. Preliminary data identify an association of the extent of severity of OSA and progressive prolongation of the corrected QT interval in LQTS.

Condition or disease Intervention/treatment Phase
Long QT Syndrome Sleep Apnea Device: Continuous Positive Airway Pressure (CPAP) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Obstructive Sleep Apnea and Cardiac Electrophysiologic Biomarkers of Sudden Cardiac Death
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019


Arm Intervention/treatment
Sleep Apnea ahi > 5
If Sleep Apnea index is > 5 and diagnosed with Long QT Syndrome
Device: Continuous Positive Airway Pressure (CPAP)
If diagnosed with Long QT Syndrome and have Sleep Apnea index >5 pauses per hour then given CPAP to wear for approximately 3 months.




Primary Outcome Measures :
  1. QT Interval (Corrected) Baseline Visit [ Time Frame: The continuous ECG will be collected for 24 hours and the overnight polysomnography will be the duration of their sleep for the night. ]
    To examine the extent that OSA severity and degree of hypoxia are associated with QT interval prolongation (primary outcome) and novel T wave morphologic assessments (secondary outcome) on serial hourly 12-lead ECG collected during overnight polysomnography and also corrected QT interval (QTc) from daytime 12-lead ECG .

  2. QT Interval (Corrected) Follow up Visit [ Time Frame: The continuous ECG will be collected for 24 hours and the overnight polysomnography will be the duration of their sleep for the night. This will be collected at their follow up visit after wearing CPAP for 2-3 months. ]
    To examine the extent that OSA severity and degree of hypoxia are associated with QT interval prolongation (primary outcome) and novel T wave morphologic assessments (secondary outcome) on serial hourly 12-lead ECG collected during overnight polysomnography and also corrected QT interval (QTc) from daytime 12-lead ECG .


Secondary Outcome Measures :
  1. Effect of OSA treatment on QT interval duration [ Time Frame: After wearing CPAP for approximately 2-3 month the continuous ECG will be collected for 24 hours and the overnight polysomnography will be the duration of their sleep for the night. ]
    To investigate the change in LQTS after OSA treatment with 2-3 month continuous positive airway pressure (CPAP) on QT interval duration as well as novel biomarkers of T wave morphology observed on ECG data collected during overnight polysomnography and also QTc collected from daytime 12-lead ECG in those with LQTS.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of QT prolongation as described above
  • Age 18-75 years
  • Individuals able to participate in at least 2 overnight sleep and hysiologic assessments over a 3 month period.

Exclusion Criteria:

  • Use of specific OSA treatments (CPAP, oral appliances)
  • Use of supplemental oxygen
  • Severe chronic insomnia
  • Circadian rhythm disorder (e.g. shift work sleep disorder, delayed or advanced sleep phase syndrome)
  • Insufficient sleep syndrome defined by reported sleep duration < 4 hours
  • Unstable medical conditions (e.g., new onset or changing angina, a myocardial infarction or congestive heart failure exacerbation documented within the previous 3 months, uncontrolled hypertension (BP>170/110), uncontrolled diabetes mellitus (HbA1c>9.0), uncontrolled hypo- or hyperthyroidism)
  • Psychiatric disorders which are inadequately treated
  • Compromised competence
  • Alcohol abuse (currently drinks >5 alcoholic drinks/day)
  • Inability to provide informed consent
  • Illicit drug use over last 6 months.

Rationale for criteria:

Patients with sleep disorders will be excluded as other sleep disorders may influence arrhythmogenesis.

Those on treatment for SDB will be excluded because treatment would preclude assessment of OSA pathophysiologic effects on QT biomarkers.

Those with unstable medical conditions or rapid or uncontrolled heart rate will be excluded due to safety reasons.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678311


Contacts
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Contact: Joan Aylor, BA 216-445-1698 aylorj@ccf.org
Contact: Rawan Nawabit 216-445-1593 nawabir@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Joan E Aylor, BA    216-445-1698    aylorj@ccf.org   
Contact: Rawan E Nawabit    216-445-1593    nawabir@ccf.org   
Principal Investigator: Reena Mehra, MD         
Sponsors and Collaborators
The Cleveland Clinic
MetroHealth Medical Center
Investigators
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Principal Investigator: Reena Mehra, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Reena Mehra, MD, The Cleveland Clinic:

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Responsible Party: Reena Mehra, MD, Director, Sleep Disorders Research, Neurologic Institute, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03678311     History of Changes
Other Study ID Numbers: 16-1433
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to make available de-identified, non-sensitive, individual-level information on objective sleep characteristics, subjective sleep health and medical history (e.g. comorbid factors and medication use) and sociodemographics (e.g., age, gender education level). We will submit the data generated from the current proposal to the NIH funded National Sleep Research Resource (NSRR). The National Sleep Research Resource (NSRR) offers free web access to large collections of de-identified physiological signals and clinical data elements collected in well-characterized research cohorts and clinical trials. The NSRR is a public resource which provides opportunities for investigators to address critical scientific questions of interest.
Supporting Materials: Study Protocol
Time Frame: When the study is complete.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Syndrome
Apnea
Sleep Apnea Syndromes
Long QT Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities