N/A
N=9
Long QT Syndrome and Sleep Apnea
Long QT Syndrome · Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT03678311 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: QT Interval (Corrected) Baseline Visit — 453.4 square root of seconds — p=0.73
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Positive Airway Pressure (CPAP) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY QT Interval (Corrected) Baseline Visit |
453.4 | 0.73 |
| PRIMARY QT Interval (Corrected) Follow up Visit |
— | — |
| SECONDARY Effect of OSA Treatment on QTc |
— | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT03678311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.