ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12618000757213

Ethics application status

Approved

Date submitted

23/04/2018

Date registered

4/05/2018

Date last updated

10/08/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Daily variation in sleep apnea status and atrial fibrillation.

Scientific title

Night-to-night variability in severity of sleep apnea and daily dynamic atrial fibrillation risk.

Secondary ID [1]

None.

Universal Trial Number (UTN)

U1111-1212-7527

Trial acronym

VARIOSA-AF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sleep Apnea

Atrial Fibrillation

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Observational Study:
Daily data on atrial fibrillation burden and average respiratory disturbance index (RDI, sleep apnea status)) were extracted from a sample of Reply 200 or Kora 100 DR pacemakers in 72 patients with a mean follow-up per patient of 21±7 weeks. Nightly RDI within each patient was grouped into quartiles, with the highest quartile representing the 25% of nights with most severe SDB for that particular patient. A daily cumulative AF-burden of >5 mins, >1 hr and >12 hrs per day were the outcome variables.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Daily cumulative atrial fibrillation burden (> 5 minutes) as assessed by pacemaker data extraction.

Timepoint [1]

Assessed daily for an average follow up of 21±7 weeks.

Secondary outcome [1]

Daily SDB-severity assessed by pacemaker data extraction.

Timepoint [1]

Assessed daily for an average follow up of 21±7 weeks.

Eligibility

Key inclusion criteria

Implanted dual-chamber pacemakers Reply 200 or Kora 100 DR (LivaNova, France) with implemented SDB monitoring (SAM) measuring a respiratory disturbance index (RDI)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- <1 month of follow-up since implant
- SDB monitoring (SAM) turned off
- >10% invalid RDI
- unreliable mode switch estimates due to atrial under sensing
- persistent AF throughout the recording

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

Data are described by mean ± standard deviation when normally distributed and median [IQR] if data follow a skewed distribution. Categorical data are expressed as percentage with numerator and denominator in brackets. A binary logistic generalized estimating equation (GEE) was used to develop a prediction model for the dichotomous AF outcome (>5 mins OR >1 hr OR >12 hrs of cumulative mode switch per day) using the within-patient standardized (via quartiles) sleep severity data.
All data will be analyzed using SPSS (Version 24) and significance was set at p<0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

23/10/2017

Date of last participant enrolment

Anticipated

Actual

27/04/2018

Date of last data collection

Anticipated

Actual

27/04/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Center for Heart Rhythm Disorders.

Address [1]

Centre for Heart Rhythm Disorders,
Department of Cardiology, Royal Adelaide Hospital,
North Terrace
Adelaide,
South Australia 5000
AUSTRALIA

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Center for Heart Rhythm Disorders.

Address

Centre for Heart Rhythm Disorders,
Department of Cardiology, Royal Adelaide Hospital,
North Terrace
Adelaide,
South Australia 5000
AUSTRALIA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Human Research Ethics Committee

Ethics committee address [1]

Central Adelaide Local Health Network
Royal Adelaide Hospital Human Research Ethics Committee
Level 4, Women’s Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide, South Australia, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/02/2017

Approval date [1]

26/04/2017

Ethics approval number [1]

HREC/17/RAH/53

Summary

Brief summary

The diagnosis of sleep-disordered breathing (SDB) is associated with increased incidence and prevalence of atrial fibrillation (AF). However, nightly SDB-severity rather than the categorical diagnosis of SDB may directly influence AF-risk during the respective day thereby creating a dynamic substrate for AF. While chronic structural alterations induced by SDB have been already described in AF patients with SDB, the role of night-to-night variability in SDB severity is unclear and clinical evidence for a dynamic AF substrate in patients related to nightly SDB severity is lacking. By simultaneous long-term night-by-night SDB and AF monitoring, we examine the dynamic intra-individual relationship between daily SDB-severity and risk of incident AF during the respective day.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Dominik Linz

Address

Centre for Heart Rhythm Disorders,
Department of Cardiology, Royal Adelaide Hospital,
North Terrace
Adelaide,
South Australia 5000
AUSTRALIA

Country

Australia

Phone

+61882222723

Fax

+61882222722

Dominik.Linz@adelaide.edu.au

Contact person for public queries

Name

Dominik Linz

Address

Centre for Heart Rhythm Disorders,
Department of Cardiology, Royal Adelaide Hospital,
North Terrace
Adelaide,
South Australia 5000
AUSTRALIA

Country

Australia

Phone

+61882222723

Fax

+61882222722

Dominik.Linz@adelaide.edu.au

Contact person for scientific queries

Name

Dominik Linz

Address

Centre for Heart Rhythm Disorders,
Department of Cardiology, Royal Adelaide Hospital,
North Terrace
Adelaide,
South Australia 5000
AUSTRALIA

Country

Australia

Phone

+61882222723

Fax

+61882222722

Dominik.Linz@adelaide.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Variability of Sleep Apnea Severity and Risk of Atrial Fibrillation: The VARIOSA-AF Study.	2019	https://dx.doi.org/10.1016/j.jacep.2019.03.005

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically