Sleep-disordered breathing in patients with implanted cardiac devices: assessment of the change in sensitivity to carbon dioxide with cardiac resynchronisation therapy

Sleep-disordered breathing in patients with implanted cardiac devices: assessment of the change in sensitivity to carbon dioxide with cardiac resynchronisation therapy - an observational case-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN99704819

Enrollment

Registered

2014-06-25

Start date

2014-04-09

Completion date

Unknown

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular disease

Interventions

This trial tests how the depth and frequency of breathing changes with rising inspired carbon dioxide levels. This relationship is tested before and after implantation of a biventricular pacemaker for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Heart failure (of any aetiology) and a reduced ejection fraction (<40%) due to undergo implantation of a Boston Scientific biventricular pacemaker or defibrillator with the ApneaScan function 2. They must meet UK guidelines for biventricular pacemaker implantation 3. They should be on optimal medical therapy for heart failure 4. They must be aged 18 or over and be able to give valid written consent for this study 5. They must be ambulatory Target Gender: Male & Female; Upper Age Limit 100 years ; Lower Age Limit 18 years

Exclusion criteria

Exclusion criteria: 1. Patients receiving pacemakers without the ApneaScan function 2. Patients unable or unwilling to attend follow-up testing 3. Patients receiving devices for indications other than heart failure with reduced ejection fraction 4. Patients with obstructive sleep apnea already on continuous positive airway pressure (CPAP) therapy 5. Patients unable to walk

Design outcomes

Primary

Measure	Time frame
Hypercapnic Ventilatory Response; Timepoint(s): Change in Minute Ventilation per unit rise in end tidal CO2	—

Secondary

Measure	Time frame
Apnoeic-Hypopnoeic Index; Timepoint(s): Measured at 6 weeks and 6 months post-implantation of pacemaker	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026