Long QT Syndrome and Sleep Apnea

Completed · Not applicable

Conditions studied: Long QT Syndrome, Sleep Apnea

In brief

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.

Key facts

Study ID

NCT03678311

Run by

The Cleveland Clinic

People needed

9

Starts

2019-03-13

Expected to finish

2019-04-30

Last updated by the study team

2020-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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