The main objective of this study is to develop a new screening method for CSA in CHF patients, combining adjusted questionnaires, overnight pulse oximetry, the Snore Detector Pro app and the so-called Zzzx app.
ID
Source
Brief title
Condition
- Other condition
- Heart failures
Synonym
Health condition
Centraal slaap apneu
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be four percentages (the percentage of *total* who
have both a positive PG and >=15 dips/hour, the percentage of *total* who have
a positive PG and <=15 dips/hour, the percentage of *total* who have a negative
PG and >= 15 dips/hour, the percentage of *total* who have a negative PG and <=
15 dips/hour), depicted in a 2 x 2 table.
Secondary outcome
The percentage of dectected CSA in the study population
The sensitivity and specificity of pulse oximetry to detect CSAS by saturation
dips > 15/h.
Differences in mean dips per hour in all 26 patients for three consecutive
nights
The differences in mean dips per hour between the Masimo iSpO2 smart device and
the oximeter which is part of the PG
The percentage of detected sleep apnea by the Snore Detector Pro app, the Apnea
app and the ZZZx app
Background summary
Central sleep apnea (CSA) is associated with increased mortality in congestive
heart failure (CHF) patients. Current golden standard for CSA diagnosis in CHF
patients is polysomnography (PSG). PSG is a burden to the patient and time
consuming to technicians, making it unsuitable as screening method. Possible
screening methods may include an app registering one*s breathing pattern and
indicating whether CSA is likely, a smartphone compatible device registering
overnight oximetry as well as an adjusted questionnaire.
Study objective
The main objective of this study is to develop a new screening method for CSA
in CHF patients, combining adjusted questionnaires, overnight pulse oximetry,
the Snore Detector Pro app and the so-called Zzzx app.
Study design
This study is a single-arm blinded observational study.
Study burden and risks
All the devices used in this study are battery powered and electrically safe.
The devices used for overnight measurement, especially the polygraphy, may
cause discomfort during sleep. A potential benefit for study participants is
early detection of CSA, as well as enabling the cardiology and pulmonary
department to develop a new screening method, which can be used in the same
patients in the future.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Stable heart failure
No change in medication for four weeks
No evidence of fluid retention at the time of the study
Only standard medical treatment, defined as an ACE inhibitor in combination with diuretics to control pulmonary or pedal edema. Digoxin and beta blockers are not considered to be standard treatment for heart failure
Heart failure defined as: EF < 45% (according to echocardiography)
CHF due to either ischaemic, non-ischaemic, or hypertensive cardiomyopathy
Exclusion criteria
Patients with known obstructive sleep apnea
Patients with known pulmonary disorder
Patients with known stroke
Patients have a life-expectancy of <=12 weeks
Patients are unwilling to sign the informed consent form
Use of oxygen
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54101.058.15 |