Trial Outcomes & Findings for Influence of Sleep Apnea on Risk of Atrial Fibrillation (NCT NCT02576587)

NCT ID: NCT02576587

Last Updated: 2018-08-15

Results Overview

Patients with diagnosis of PAF were defined as cases. PAF is the primary outcome of baseline analysis, which aimed to quantify the association of sleep apnea and PAF.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 317 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2018-08-15

Participant Flow

Participant milestones

Measure	Case (Diagnosed With PAF) Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Baseline STARTED	161	156
Baseline COMPLETED	161	155
Baseline NOT COMPLETED	0	1
Follow up Period (Case Only) STARTED	161	155
Follow up Period (Case Only) Selected for Follow up	61	0
Follow up Period (Case Only) COMPLETED	44	0
Follow up Period (Case Only) NOT COMPLETED	117	155

Reasons for withdrawal

Measure	Case (Diagnosed With PAF) Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Baseline Equipment failure	0	1
Follow up Period (Case Only) Withdrawal by Subject	25	0
Follow up Period (Case Only) Not selected for follow up (AHI<15)	92	0
Follow up Period (Case Only) Controls not eligible for followup	0	155

Baseline Characteristics

Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.

Baseline characteristics by cohort

Measure	Case (Diagnosed With PAF) n=150 Participants Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases completed baseline and having matched controls were included in baseline data analysis.	Controls n=150 Participants Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics. Controls completed baseline and having matched cases were included in baseline data analysis.	Total n=300 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 12 • n=150 Participants	62 years STANDARD_DEVIATION 12 • n=150 Participants	61 years STANDARD_DEVIATION 12 • n=300 Participants
Sex: Female, Male Female	55 Participants n=150 Participants	55 Participants n=150 Participants	110 Participants n=300 Participants
Sex: Female, Male Male	95 Participants n=150 Participants	95 Participants n=150 Participants	190 Participants n=300 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=150 Participants	1 Participants n=150 Participants	2 Participants n=300 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	149 Participants n=150 Participants	149 Participants n=150 Participants	298 Participants n=300 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=150 Participants	0 Participants n=150 Participants	0 Participants n=300 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=150 Participants	0 Participants n=150 Participants	0 Participants n=300 Participants
Race (NIH/OMB) Asian	2 Participants n=150 Participants	2 Participants n=150 Participants	4 Participants n=300 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=150 Participants	0 Participants n=150 Participants	0 Participants n=300 Participants
Race (NIH/OMB) Black or African American	22 Participants n=150 Participants	22 Participants n=150 Participants	44 Participants n=300 Participants
Race (NIH/OMB) White	125 Participants n=150 Participants	125 Participants n=150 Participants	250 Participants n=300 Participants
Race (NIH/OMB) More than one race	1 Participants n=150 Participants	1 Participants n=150 Participants	2 Participants n=300 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=150 Participants	0 Participants n=150 Participants	0 Participants n=300 Participants
Region of Enrollment United States	150 participants n=150 Participants	150 participants n=150 Participants	300 participants n=300 Participants
Body Mass Index	31 kg/m^2 STANDARD_DEVIATION 7 • n=150 Participants	32 kg/m^2 STANDARD_DEVIATION 7 • n=150 Participants	31 kg/m^2 STANDARD_DEVIATION 7 • n=300 Participants
Apnea Hypopnea Index (AHI)	11 apneas plus hypopneas per hour n=150 Participants	13 apneas plus hypopneas per hour n=150 Participants	12 apneas plus hypopneas per hour n=300 Participants
Arousal Index	18 Arousals per hour n=150 Participants	19 Arousals per hour n=150 Participants	19 Arousals per hour n=300 Participants
Central Apnea Index	0 Central apneas per hour n=150 Participants	0 Central apneas per hour n=150 Participants	0 Central apneas per hour n=300 Participants
Percent sleep time with oxygen saturation<90%	0.4 percent of sleep time n=150 Participants	0.4 percent of sleep time n=150 Participants	0.4 percent of sleep time n=300 Participants
Left Atrial Volume	63 mL n=135 Participants • Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.	51 mL n=135 Participants • Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.	60 mL n=270 Participants • Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.
Left Atrial Volume Index	30 mL/m^2 n=134 Participants • Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.	28 mL/m^2 n=134 Participants • Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.	29 mL/m^2 n=268 Participants • Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.
Left Atrial Systolic Strain by apical four-chamber (A4C) view	34 percent of left atrial volume n=107 Participants • Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.	33 percent of left atrial volume n=107 Participants • Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.	33 percent of left atrial volume n=214 Participants • Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.
Left Atrial Systolic Strain by apical two-chamber (A2C) view	34 percent of left atrial volume n=106 Participants • Echo measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.	35 percent of left atrial volume n=106 Participants • Echo measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.	35 percent of left atrial volume n=212 Participants • Echo measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.
High Blood Pressure or Hypertension	87 Participants n=150 Participants	79 Participants n=150 Participants	166 Participants n=300 Participants
High Blood cholesterol	86 Participants n=150 Participants	91 Participants n=150 Participants	177 Participants n=300 Participants
History of heart attack	9 Participants n=150 Participants	16 Participants n=150 Participants	25 Participants n=300 Participants
Depression	22 Participants n=150 Participants	35 Participants n=150 Participants	57 Participants n=300 Participants
Diabetes	19 Participants n=150 Participants	23 Participants n=150 Participants	42 Participants n=300 Participants
Use of Calcium blocker	20 Participants n=150 Participants	8 Participants n=150 Participants	28 Participants n=300 Participants
Use of beta blocker	85 Participants n=150 Participants	35 Participants n=150 Participants	120 Participants n=300 Participants
Any use of antihypertension medications	121 Participants n=150 Participants	69 Participants n=150 Participants	190 Participants n=300 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Cases and controls who had matched control/case were included in baseline analysis. Only 150 cases were one-to-one matched with controls.

Patients with diagnosis of PAF were defined as cases. PAF is the primary outcome of baseline analysis, which aimed to quantify the association of sleep apnea and PAF.

Outcome measures

Measure	Case (Diagnosed With PAF) n=150 Participants Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls n=150 Participants Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Number of Participants With Paroxymal Atrial Fibrillation (PAF)	150 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and 12 week follow up

Population: Cases found to have an apnea hypopnea index \>=15 were asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine.

Increased left atrial volume and strain are known risk factors of AF and PAF. Echocardiography measurements were not available for some subjects due to image quality.

Outcome measures

Measure	Case (Diagnosed With PAF) n=43 Participants Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls n=39 Participants Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Echocardiography Measures- Left Atrial Volume	67 mL Interval 52.0 to 79.0	72 mL Interval 55.0 to 80.0

SECONDARY outcome

Timeframe: Baseline and 12 week follow up

Increased left atrial volume and strain are known risk factors of AF and PAF. Left atrial volume index (LAVI) is left atrial size indexed to Body surface area (BSA). The reference range of LAVI is 16-28 mL/m^2.

Mildly abnormal: 29-33 mL/m^2; Moderately abnormal: 34-39 mL/m^2; Severely abnormal: greater than or equal to 40 mL/m^2.

Echocardiography measurements were not available for some subjects due to image quality.

Outcome measures

Measure	Case (Diagnosed With PAF) n=42 Participants Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls n=38 Participants Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Echocardiographic Measures- LA Volume Index	31 mL/m^2 Interval 23.0 to 37.0	30 mL/m^2 Interval 24.0 to 38.0

SECONDARY outcome

Timeframe: Baseline and 12 week follow up

Left atrial systolic strain, a measure of left atrial remodeling which is inversely related to fibrosis in PAF, is measured by 2-dimensional echocardiography. Apical four-chamber (A4C) and two-chamber (A2C) views are the most commonly used approaches to measure the strain rate (%) of left atrial.

Outcome measures

Measure	Case (Diagnosed With PAF) n=34 Participants Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls n=32 Participants Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Echocardiographic Measures- LA Systolic Strain by A4C View	36 percentage of left atrial volume Interval 24.0 to 46.0	29 percentage of left atrial volume Interval 23.0 to 38.0

SECONDARY outcome

Timeframe: Baseline and 12 week follow up

Left atrial systolic strain, a measure of left atrial remodeling which is inversely related to fibrosis in PAF, is measured by 2-dimensional echocardiography. Apical four-chamber (A4C) and two-chamber (A2C) views are the most commonly used approaches to measure the strain rate (%) of left atrial.

Outcome measures

Measure	Case (Diagnosed With PAF) n=34 Participants Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls n=31 Participants Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Echocardiographic Measures- LA Systolic Strain by A2C View	36 percentage of left atrial volume Interval 27.0 to 41.0	37 percentage of left atrial volume Interval 28.0 to 45.0

SECONDARY outcome

Timeframe: Baseline and 12 week follow up

Population: Cases selected for follow-up and having available SphygmoCor measurements

Radial measurements were performed on the same arm using the SphygmoCor device after sphygmomanometric pressure was obtained with use of an applanation tonometry probe containing a solid state high fidelity Millar transducer over the radial artery with a minimum of two consecutive measurements to obtain pulse wave analysis results. For pulse wave velocity, lead II ECG (LL, LA, RA) was performed along with cardotid and femoral applanation tomometry. Orientation and pressure applied to the transducer were adjusted to optimize applanation of the artery between the transducer and the underlying tissue. Waveforms were processed using the SphygmoCor software (model EM3, version CvMS 9.0, Atcor Medical Pty, West Ryde, Australia).)

Outcome measures

Measure	Case (Diagnosed With PAF) n=14 Participants Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls n=10 Participants Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Vascular Measures- Pulse Wave Velocity	9.5 m/s Standard Deviation 2.7	10.5 m/s Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline and 12 week follow up

Population: Cases selected for follow-up and having available SphygmoCor measurements

Augmentation Index (Alx) is an indication of systemic arterial stiffness and measures the contributions of wave reflection to central systolic pressure. Scores vary based on age and gender and in a normal, healthy population research has shown can range from -10% or less up to 50%. A negative augmentation index suggests low artery stiffness (late arriving wave reflections) and a positive index is a reflection of increase artery stiffness (reflective wave arriving early in the cardiac cycle). Waveforms will be processed using the SphygmoCor software (model EM3, version CvMS 9.0, Atcor Medical Pty, West Ryde, Australia) for this measurement.

It is calculated at the onset of reflected wave, Alx = AP/PP x 100. Alx = Augmentation Index, the percentage of the pulse pressure due to the AP; PP = Pulse Pressure; AP = Augmentation Pressure, the contribution of the reflected wave to the pulse pressure.

Outcome measures

Measure	Case (Diagnosed With PAF) n=17 Participants Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls n=17 Participants Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Vascular Measures- Augmentation Index	28.6 percentage of augmentation pressure Standard Deviation 13.2	26.9 percentage of augmentation pressure Standard Deviation 11.6

Adverse Events

Case (Diagnosed With PAF)

Serious events: 7 serious events

Other events: 22 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Case (Diagnosed With PAF) n=161 participants at risk Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls n=155 participants at risk Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Injury, poisoning and procedural complications Hit by Automobile	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Nervous system disorders Headache	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Surgical and medical procedures Elective Tummy Tuck Surgery	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Surgical and medical procedures Elective Ablation for Atrial Fibrillation	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Cardiac disorders High Blood Pressure (went to ER)	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Gastrointestinal disorders Obstructed Bowel	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Surgical and medical procedures Elective - Total Knee Replacement	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.

Other adverse events

Measure	Case (Diagnosed With PAF) n=161 participants at risk Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study. Cases found to have an apnea hypopnea index \>=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine. Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.	Controls n=155 participants at risk Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.
Musculoskeletal and connective tissue disorders Muscle and skeletal pain from Echocardiogram	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Skin and subcutaneous tissue disorders Itching/inflammation fron ECG pads	4.3% 7/161 • Number of events 7 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Skin and subcutaneous tissue disorders Itching head from CPAP headwear	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Skin and subcutaneous tissue disorders Poison Ivy	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Cardiac disorders Heart Rate 130-190 bpm	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Injury, poisoning and procedural complications Injured Knee in shower	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Injury, poisoning and procedural complications Nail puctured hand	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
General disorders Runny nose with CPAP use	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Surgical and medical procedures Umbilical hernia repair	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
General disorders Bloody nose (slight) upon wakening	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Injury, poisoning and procedural complications Twisted ankle	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Cardiac disorders Continuous ECG Alert	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Cardiac disorders A-Fib went to ER	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Injury, poisoning and procedural complications Fell off motorcycle	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.
Cardiac disorders A-fib with shortness of breath	0.62% 1/161 • Number of events 1 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.	0.00% 0/155 • Adverse events were collected on all participants during their overnight visit. Participants (cases) which qualified for CPAP, adverse events were collected over a 3 month period while wearing CPAP.

Additional Information

Dr. Reena Mehra

Cleveland Clinic

Phone: 216-444-4946

Email: mehrar@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place