NCT00263757

Brief Summary

This randomized, controlled trial is designed to test whether treatment of sleep disordered breathing (SDB) with positive airway pressure (PAP) therapy alters the natural history of atrial fibrillation (AF). Patients with recent AF who are now in sinus rhythm, and found to have SDB (obstructive and/or central sleep apnea) by formal sleep study but without complaints of daytime sleepiness, are randomized to PAP therapy to eradicate SDB or to usual care (medical management as prescribed by the patient's cardiologist).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2005

Completed
3.8 years until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

2.6 years

First QC Date

December 7, 2005

Results QC Date

May 30, 2014

Last Update Submit

July 7, 2014

Conditions

Sleep ApneaAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year

    1 year

Secondary Outcomes (2)

  • Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit

    baseline, 12 months

  • Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)

    baseline, 12 months

Study Arms (2)

Therapeutic Positive Airway Pressure

EXPERIMENTAL

Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.

Device: Adaptive Servo-Ventilation

Usual Care

OTHER

Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.

Other: Usual Care

Interventions

Adaptive Servo-VentilationDEVICE

Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.

Therapeutic Positive Airway Pressure
Usual CareOTHER

Subjects randomized to this arm received medical management as prescribed by their cardiologist.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 yrs
  • Successful electrical or chemical cardioversion within previous 2 weeks
  • Greater than 2 episodes symptomatic AF in previous 6 months

You may not qualify if:

  • Currently on PAP therapy
  • Moderate to severe pulmonary disease
  • Neurologic impairment (h/o cerebrovascular accident (CVA), transient ischemic attack (TIA), neuromuscular disease, diaphragmatic paralysis)
  • Severe cardiac disease (LVEF\<40%, greater than mild to moderate valvular disease)
  • Post cardiac surgery AF
  • Congenital heart disease
  • Renal disease (Scr \> 2.5)
  • Excessive ethanol (EtOH) use (\>2 drinks/day)
  • Anatomically fixed nasal obstruction (severe septal deviation, uncontrolled rhinitis)
  • History of motor vehicle or occupational accident related to sleepiness.
  • Epworth Sleepiness Scale score \>18 (out of maximum score of 24).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Caples SM, Mansukhani MP, Friedman PA, Somers VK. The impact of continuous positive airway pressure treatment on the recurrence of atrial fibrillation post cardioversion: A randomized controlled trial. Int J Cardiol. 2019 Mar 1;278:133-136. doi: 10.1016/j.ijcard.2018.11.100. Epub 2018 Nov 20.

    PMID: 30522886DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesAtrial Fibrillation

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

The primary barrier to enrollment was the high rate of subjects who were previously diagnosed with sleep apnea and were already prescribed treatment.

Results Point of Contact

Title
Dr. Sean M. Caples
Organization
Mayo Clinic
Caples.Sean@mayo.edu
507-293-1031

Study Officials

  • Sean M. Caples, D.O.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2005

First Posted

December 9, 2005

Study Start

October 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 1, 2014

Results First Posted

August 1, 2014

Record last verified: 2014-07

Locations

US(1)