NCT05435001 is a NA clinical trial of Holter ECG Monitoring in Sleep Apnea Syndromes, sponsored by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital.

What drugs are being tested in NCT05435001?

Interventions in NCT05435001: Holter ECG Monitoring.

What condition does NCT05435001 study?

NCT05435001 studies Sleep Apnea Syndromes.

Is NCT05435001 still recruiting?

NCT05435001 is currently completed. Last updated 21 February 2023.

Last reviewed 2023-02-21 · How we verify

NCT05435001

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Screening of Sleep Apnea by Holter Electrocardiography: Validation of Heart Rate Variability Analysis Algorithm

Completed NA Last updated 21 February 2023

What this trial tests

NA trial testing Holter ECG Monitoring in Sleep Apnea Syndromes in 107 participants. Completed in 1 August 2022.

Timeline

5 May 2022

Primary endpoint
1 July 2022

1 August 2022

Quick facts

Lead sponsor	Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	107
Start date	5 May 2022
Primary completion	1 July 2022
Estimated completion	1 August 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

Holter ECG Monitoring

Conditions studied

Sleep Apnea Syndromes — all drugs for Sleep Apnea Syndromes →

Sponsor

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Who can join

Adults 18 to 80, any sex, with Sleep Apnea Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obstructive sleep apnea syndrome (OSAS) is a growing health concern affecting up to 60 % of population with cardiovascular disease. Despite the high cardiovascular morbidity and mortality associated with this syndrome, the substantial inconvenience and cost of polysomnography recordings may delay routine evaluation. Polysomnography (PSG) is the gold standard for diagnosis. However, this is a costly and time-consuming examination. Sympathoadrenergic balance obtained from the routine Holter monitoring suggesting the presence of OSAS, can enable patients to be guided and their PSGs to be primarily held.Abnormalities in nocturnal cyclical heart rate (HR) variations have previously been described in sleep-related breathing disorders. Compared with PSG, holter electrocardiogram has the advantages of pervasion, lower cost, no need for overnight hospitalization, greater similarity to normal conditions, and good compliance. The observation of changes in heart rate associated with apneic events has a potential to be used as an alternative technique for identification of subjects with OSAS. In regard to the feasibility of screening OSAS by HRV analysis by holter electrocardiogram monitoring, it has already been reported that a 24-h electrocardiographic monitoring might be useful to diagnose OSAS. It became a more feasible technique to use following the development of a convenient recorder for OSAS screening by analyzing changes in heart rate.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Sleep Apnea Syndromes

Currently open trials in the same condition.

NCT06578390 — Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis · NA · recruiting
NCT07086599 — Typological Study of Sleep Pathologies During Psoriatic Rheumatism and SAPHO Syndrome: Prospective Study Within the Pari · recruiting
NCT04399200 — Apnea, Stroke and Incident Cardiovascular Events · recruiting
NCT04234828 — Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome · active not recruiting

Other Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital trials

Trials by the same sponsor.

NCT05537974 — Open Suction vs. Closed Suction in ARDS · NA · completed
NCT05053061 — Telerehabilitation in COPD · NA · recruiting
NCT04873336 — Closed Loop Ventilation in Patients With COVID-19 · completed
NCT04715919 — Long Term Outcomes of Coronavirus Disease-19 (COVID-19) · completed
NCT03077152 — Patient Factors Associated With Prescription of Antibiotics for Inappropriate Indication in Patients With AECOPD · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05435001 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Last refreshed: 21 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05435001.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing