Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea (ELSA)

Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea (ELSA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: pulse-oximetry

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8091
      • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected obstructive sleep apnea

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected OSA	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights	"Sensitivity" and "specificity" for every additional night will be assessed	14 nights of pulse-oximetry
Decision making of a panel of experts in the field of sleep medicine regarding diagnosis and severity of OSA (no OSA, mild, moderate, severe) with/without the additional information of longitudinal sleep monitoring		14 nights of pulse-oximetry

Secondary Outcome Measures

Outcome Measure	Time Frame
ODI variability measured in 14 consecutive nights of pulse-oximetry	14 nights of pulse-oximetry
Change of OSA severity class (no OSA, mild, moderate, severe OSA) during 14 nights of pulse-oximetry due to ODI variability	14 nights of pulse-oximetry
Change of OSA severity class (no OSA, mild, moderate, severe OSA) diagnosed by in-hospital single-night sleep study vs repeated measurements by pulse-oximetry	14 nights of pulse-oximetry
Decision making of a panel of experts in field of sleep medicine regarding treatment decisions (CPAP yes/no) with/without the additional information of longitudinal sleep monitoring	14 nights of pulse-oximetry
Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA	14 nights of pulse-oximetry

Collaborators and Investigators

• Sponsor: Malcolm Kohler
• Investigators: Principal Investigator: Malcolm Kohler, Prof. Dr. med., University of Zurich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): April 30, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Oxygen Desaturation Index; Night-to-night variability; Apnoea-Hypopnoea Index; Pulse-oximetry
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2018-02305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No