Trial Outcomes & Findings for Atrial Fibrillation Recurrence in Sleep Apnea (NCT NCT00263757)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

1 year

Results posted on

2014-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Therapeutic Positive Airway Pressure Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.	Usual Care Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
Overall Study STARTED	12	13
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Therapeutic Positive Airway Pressure Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.	Usual Care Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
Overall Study Withdrawal by Subject	5	4
Overall Study Screen failure	0	1
Overall Study Adverse Event	3	3

Baseline Characteristics

Atrial Fibrillation Recurrence in Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapeutic Positive Airway Pressure n=12 Participants Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.	Usual Care n=13 Participants Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Therapeutic Positive Airway Pressure n=12 Participants Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.	Usual Care n=13 Participants Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year	3 participants	3 participants

SECONDARY outcome

Timeframe: baseline, 12 months

Population: Usual Care Arm: At the baseline visit 13 participants completed the ESS, and at the 12 month visit 6 participants completed the ESS, due to withdrawals. Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the ESS, and at the 12 month visit 5 participants completed the ESS, due to withdrawals.

The ESS is a measure of general level of sleepiness. The ESS asks subjects to rate their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily live, although not necessarily every day. The questionnaire has 8 questions, with responses ranging from 0 (would never dose) to 3 (high chance of dozing). Therefore the total score could range from 0 (no sleepiness) to 24 (high chance of dozing).

Outcome measures

Outcome measures
Measure	Therapeutic Positive Airway Pressure n=12 Participants Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.	Usual Care n=13 Participants Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit Baseline Visit, n=12, 13	4.75 units on a scale Standard Deviation 2.14	7.31 units on a scale Standard Deviation 3.33
Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit 12 Month Visit, n=5, 6	5.80 units on a scale Standard Deviation 2.59	5.67 units on a scale Standard Deviation 2.34

SECONDARY outcome

Timeframe: baseline, 12 months

Population: Usual Care Arm: At the baseline visit 13 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, some due to withdrawals. Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, due to withdrawals.

The FOSQ is a disease-specific quality of life questionnaire to determine functional status in adults. The measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living. There are 30 items on the questionnaire consisting of 5 factor subscales. The subject rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). A higher score indicates greater difficulty or impact of sleepiness on daily living. FOSQ total score ranges from 0 (no difficulty) to 120 (extreme difficulty).

Outcome measures

Outcome measures
Measure	Therapeutic Positive Airway Pressure n=12 Participants Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.	Usual Care n=13 Participants Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) Baseline visit, n=12, 13	19.08 units on a scale Standard Deviation 0.67	17.62 units on a scale Standard Deviation 1.56
Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) 12 months visit, n=4, 4	18.25 units on a scale Standard Deviation 1.50	17.50 units on a scale Standard Deviation 1.91

Adverse Events

Therapeutic Positive Airway Pressure

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Usual Care

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Therapeutic Positive Airway Pressure n=12 participants at risk Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.	Usual Care n=13 participants at risk Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
General disorders Interim hospitalization	8.3% 1/12 • Number of events 1	15.4% 2/13 • Number of events 3

Other adverse events

Other adverse events
Measure	Therapeutic Positive Airway Pressure n=12 participants at risk Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.	Usual Care n=13 participants at risk Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
Respiratory, thoracic and mediastinal disorders Worsening breathlessness during the day	0.00% 0/12	15.4% 2/13 • Number of events 3
Respiratory, thoracic and mediastinal disorders Worsening breathlessness/gasping awaken from sleep	0.00% 0/12	7.7% 1/13 • Number of events 2
Respiratory, thoracic and mediastinal disorders Chest pain at night/awakens from sleep	8.3% 1/12 • Number of events 1	7.7% 1/13 • Number of events 1

Additional Information

Dr. Sean M. Caples

Mayo Clinic

Phone: 507-293-1031

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place