Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients with Suspected Obstructive Sleep Apnea

NCT ID: NCT03819361

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2025-04-30

Brief Summary

Obstructive sleep apnea (OSA) is a highly prevalent sleep-disordered breathing disease, caused by recurrent episodes of partial or complete collapse of the upper airway during sleep, resulting in intermittent hypoxia, fragmented sleep, fluctuations in blood pressure, and increased sympathetic nervous system activity. A single-night sleep study (i.e. respiratory polygraphy or polysomnography) is currently considered to be the gold standard for diagnosing OSA. However, recent studies suggest a significant intra-individual night-to-night variability of respiratory events, leading to the hypothesis that one single-night study might not reflect an accurate picture of the disease.

Part A: Patients with suspected obstructive sleep apnea, referred to our clinic, undergo the regular diagnostic procedure recommended by the current guidelines. In addition to the in-hospital single-night sleep study, these patients will perform 14 nights of pulse-oximetry at home. By computing and analysing sensitivity and specificity of every additional night, the investigator will answer the questions how many nights of sleep monitoring by home oximetry are necessary to diagnose OSA reliably, and how longitudinal sleep monitoring could reduce the number of false-negative and false- positive results compared to the in-hospital single-night study.

Part B: Based on the patients' data of part A, the investigator will develop a questionnaire and present anonymized cases to experts in the field of sleep medicine. Thereby, the investigator will evaluate if the additional information of repeated nocturnal pulse-oximetries changes the experts' decision making regarding diagnosis and treatment of OSA.

In a second step, the investigator will perform a classical Delphi study with a panel of experts in sleep medicine to establish consensus on repeated sleep studies and how they should be used for diagnosis and treatment in patients with suspected OSA.

Conditions

Obstructive Sleep Apnea

Keywords

Night-to-night variability; Apnoea-Hypopnoea Index; Oxygen Desaturation Index; Pulse-oximetry

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Suspected OSA

pulse-oximetry

Intervention Type: DIAGNOSTIC_TEST

Patients with suspected OSA will be monitored with 14 nights of pulse-oximetry prior to the already planned in-hospital single-night sleep study at the University Hospital Zurich

Interventions

pulse-oximetry

Patients with suspected OSA will be monitored with 14 nights of pulse-oximetry prior to the already planned in-hospital single-night sleep study at the University Hospital Zurich

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Informed consent
• Suspected obstructive sleep apnea
• ≥18 years old

Exclusion Criteria

• Suspected or diagnosed sleeping-disordered breathing other than OSA
• Moribund or severe disease prohibiting protocol adherence especially COPD GOLD III-IV and heart failure NYHA III-IV
• Patients receiving oxygen therapy or home ventilation
• Continuous positive airway pressure treatment for OSA at baseline
• Physical or intellectual impairment precluding informed consent or protocol adherence
• Pregnant patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Malcolm Kohler

OTHER

Sponsor Role: lead

Responsible Party

Malcolm Kohler

Head of the department of pulmonology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Malcolm Kohler, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

Roeder M, Sievi NA, Bradicich M, Grewe FA, Siegfried S, Gaisl T, Kohler M. The Accuracy of Repeated Sleep Studies in OSA: A Longitudinal Observational Study With 14 Nights of Oxygen Saturation Monitoring. Chest. 2021 Mar;159(3):1222-1231. doi: 10.1016/j.chest.2020.09.098. Epub 2020 Sep 25.

Reference Type: DERIVED

PMID: 32980370 (View on PubMed)

Other Identifiers

2018-02305

Identifier Type: -

Identifier Source: org_study_id