Trial Outcomes & Findings for Long QT Syndrome and Sleep Apnea (NCT NCT03678311)
NCT ID: NCT03678311
Last Updated: 2020-07-02
Results Overview
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.
COMPLETED
NA
9 participants
The 12-lead ECG will be collected in the morning and the overnight polysomnography will be the duration of their sleep for the night.
2020-07-02
Participant Flow
Recruitment was delayed in starting. Start Date 3/13/2019, End Date 4/30/2019. Recruited people with a clinical diagnosis of QT Prolongation that were not on treatment for sleep disordered breathing, chronic sleep disorders, unstable medical conditions or rapid/uncontrolled heart rate (for safety reasons).
Baseline Study 9 completed, 4 qualified to continue and receive CPAP. Zero started the 3 month follow up (CPAP treatment). Because of contract issues CPAPs were not available. Study ended 4/30/2019.
Participant milestones
| Measure |
Sleep Apnea Ahi > 5
If Sleep Apnea index is \> 5 and diagnosed with Long QT Syndrome
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.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long QT Syndrome and Sleep Apnea
Baseline characteristics by cohort
| Measure |
Sleep Apnea Ahi > 5
n=9 Participants
If Sleep Apnea index is \> 5 and diagnosed with Long QT Syndrome
|
|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.8 kg/m^2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Apnea Hypopnea Index (AHI)
|
4.4 events per hour
n=5 Participants
|
|
Percent of Sleep Time with SaO2<90%
|
7 percent of sleep time
n=5 Participants
|
|
%SpO2
|
99.1 percent of oxygen saturation
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
STOPBANG
|
3.2 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Epworth Sleepiness Scale
|
9.9 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Patient Health Questionnaire-9
|
8.2 units on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: The 12-lead ECG will be collected in the morning and the overnight polysomnography will be the duration of their sleep for the night.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.
Outcome measures
| Measure |
Sleep Apnea Ahi > 5
n=9 Participants
If Sleep Apnea index is \> 5 and diagnosed with Long QT Syndrome
|
|---|---|
|
QT Interval (Corrected) Baseline Visit
|
453.4 square root of seconds
Standard Deviation 28.7
|
PRIMARY outcome
Timeframe: 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.Population: No patient started follow up (3 Month CPAP Treatment). Because of contract issues CPAPs were not available.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.Population: No patient started follow up (3 Month CPAP Treatment). Because of contract issues CPAPs were not available.
To investigate the change in LQTS after OSA treatment with 2-3 month continuous positive airway pressure (CPAP) on QTc collected from daytime 12-lead ECG in those with LQTS.
Outcome measures
Outcome data not reported
Adverse Events
Sleep Apnea Ahi >5
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place