Long QT Syndrome and Sleep Apnea

NCT03678311 | Completed Results FDA Device

• 1 other identifier: 16-1433
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Long QT Syndrome; Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• QT Interval (Corrected) Baseline Visit

  To examine the extent that OSA severity from overnight polysomnograph is associated with corrected QT interval (QTc) from daytime 12-lead ECG. The 24 hour continuous ECG is not available.

  The 12-lead ECG will be collected in the morning and the overnight polysomnography will be the duration of their sleep for the night.

• QT Interval (Corrected) Follow up Visit

  To examine the extent that OSA severity from overnight polysomnograph is associated with corrected QT interval (QTc) from daytime 12-lead ECG. The 24 hour continuous ECG is not available.

  The 12-lead ECG will be collected in the morning 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.

Secondary Outcomes (1)

• Effect of OSA Treatment on QTc

  After wearing CPAP for approximately 2-3 month the 12-lead ECG will be collected in the morning and the overnight polysomnography will be the duration of their sleep for the night.

Study Arms (1)

Sleep Apnea ahi > 5

OTHER

If Sleep Apnea index is \> 5 and diagnosed with Long QT Syndrome

Device: Continuous Positive Airway Pressure (CPAP)

Interventions

Continuous Positive Airway Pressure (CPAP) DEVICE

If diagnosed with Long QT Syndrome and have Sleep Apnea index \>5 pauses per hour then given CPAP to wear for approximately 3 months.

Sleep Apnea ahi > 5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• MetroHealth Medical Center: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Long QT Syndrome; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Limitations and Caveats

Due to factors beyond the investigators including delays in contracts within the one year scope of funding, the positive airway pressure intervention for this study could not be conducted.

Results Point of Contact

• Title: Dr. Reena Mehra
• Organization: Cleveland Clinic

mehrar@ccf.org

216-444-2165

Study Officials

• Reena Mehra, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Sleep Disorders Research, Neurologic Institute

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 19, 2018
• Study Start: March 13, 2019
• Primary Completion: April 29, 2019
• Study Completion: April 30, 2019
• Last Updated: July 2, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When the study is complete.

Locations

US (1)