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

Obstructive Sleep Apnea Clinical Trial

— ELSA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03819361
• Other study ID #: 2018-02305
• Status: Active, not recruiting
• Start date: February 1, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: September 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Malcolm Kohler

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	ODI variability measured in 14 consecutive nights of pulse-oximetry		14 nights of pulse-oximetry
Secondary	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
Secondary	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
Secondary	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
Secondary	Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA		14 nights of pulse-oximetry