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

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ClinicalTrials.gov Identifier: NCT03819361
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich

Tracking Information
First Submitted Date January 22, 2019
First Posted Date January 28, 2019
Last Update Posted Date July 12, 2019
Actual Study Start Date February 1, 2019
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2019)
  • The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights [ Time Frame: 14 nights of pulse-oximetry ]
    "Sensitivity" and "specificity" for every additional night will be assessed
  • 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 [ Time Frame: 14 nights of pulse-oximetry ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03819361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 25, 2019)
  • ODI variability measured in 14 consecutive nights of pulse-oximetry [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 14 nights of pulse-oximetry ]
  • Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA [ Time Frame: 14 nights of pulse-oximetry ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with suspected obstructive sleep apnea
Condition Obstructive Sleep Apnea
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
Study Groups/Cohorts Suspected OSA
Intervention: Diagnostic Test: pulse-oximetry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 25, 2019)
130
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Malcolm Kohler, Prof. Dr. med. +41 44 255 38 28 malcolm.kohler@usz.ch
Contact: Maurice Roeder, Dr. med. +41 44 255 4801 maurice.roeder@usz.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03819361
Other Study ID Numbers 2018-02305
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Malcolm Kohler, University of Zurich
Study Sponsor Malcolm Kohler
Collaborators Not Provided
Investigators
Principal Investigator: Malcolm Kohler, Prof. Dr. med. University of Zurich
PRS Account University of Zurich
Verification Date January 2019