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

NCT03819361 | Active Not Recruiting

• 1 other identifier: 2018-02305
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

Suspected OSA

Diagnostic Test: pulse-oximetry

Interventions

pulse-oximetry 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

Suspected OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected obstructive sleep apnea

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Malcolm Kohler: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32980370 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Malcolm Kohler, Prof. Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the department of pulmonology

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 28, 2019
• Study Start: February 1, 2019
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)