Clinical trial NCT03819361: Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients with Suspected Obstructive Sleep Apnea
Official title: Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients with Suspected Obstructive Sleep Apnea (ELSA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Night-to-night variability
Apnoea-Hypopnoea Index
Oxygen Desaturation Index
Pulse-oximetry
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected obstructive sleep apnea

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.


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

Primary outcomes:
measure: The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights
timeFrame: 14 nights of pulse-oximetry
measure: 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
timeFrame: 14 nights of pulse-oximetry
Secondary outcomes:
measure: ODI variability measured in 14 consecutive nights of pulse-oximetry
timeFrame: 14 nights of pulse-oximetry
measure: Change of OSA severity class (no OSA, mild, moderate, severe OSA) during 14 nights of pulse-oximetry due to ODI variability
timeFrame: 14 nights of pulse-oximetry
measure: 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
timeFrame: 14 nights of pulse-oximetry
measure: 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
timeFrame: 14 nights of pulse-oximetry
measure: Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA
timeFrame: 14 nights of pulse-oximetry
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
affiliation: University of Zurich
name: Malcolm Kohler, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.