The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea

NCT03232658 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2019-02-28

No results posted yet for this study

Summary

Obstructive sleep apnea (OSA) is a common nocturnal breathing disorder characterized by complete (apnea) and partial (hypopnea) breathing cessations during sleep. Currently, clinical diagnosis of OSA is based on the clinical symptoms, especially excessive daytime sleepiness, and apnea-hypopnea index (AHI) providing a limited overview of the breathing cessation event frequency during the night. Longer obstruction events and deeper desaturations have been suggested to be more harmful than shorter and shallower events and these individual characteristics are completely neglected by conventional and currently used AHI.

The investigators have previously introduced novel diagnostic parameters incorporating the number, duration and morphology of individual obstruction events and shown that they improve the severity estimation of OSA compared to traditional measures. Even though, the novel diagnostic parameters have so far tackled some of shortcomings of AHI, they need to be refined to further increase the accuracy of the OSA severity estimation.

It has been shown that age, body mass index (BMI) and sleeping position are strongly related to the severity OSA. However, it is not thoroughly studied whether the severity of individual obstruction events progress over time (the aging process) and which factors affect to this progression. It is known that OSA patients with similar AHI values, durations of individual breathing cessation events can differ significantly. Longer and deeper events are connected to increased mortality rate in patients with moderate or severe OSA and thus, could be considered to be more detrimental than shorter and shallower ones. However, it has not been thoroughly investigated whether in severe OSA patients with identical AHI values, sleep efficiency or hypertension is related to the severity of individual breathing cessation events.

The investigators planned to explore, whether the individual breathing cessation event severity progress over time and how different confounding factors affect this progression. Furthermore, the correlation of EDS with the individual breathing cessation event severity, sleep structure, and frequency and occurrence of cortical arousals will be investigated. Also, the investigators will explore whether the percentage time of disturbed breathing from total sleep time is related to sleep efficiency or hypertension in severe OSA patients having similar AHI. Moreover, Positional therapy (PT) i.e., the avoidance of the supine posture during sleep is the treatment of choice for Positional Patients (PP) having most of their breathing abnormalities while sleeping supine. Since it is known that apneas/hypopneas are more severe while sleeping supine, this time the investigators will assess the therapeutic value of PT for severe Non Positional patients (NPP).

Conditions

Sponsors & Collaborators

  • University of Eastern Finland

    collaborator OTHER
  • Seinajoki Central Hospital

    collaborator OTHER
  • Kuopio University Hospital

    collaborator OTHER
  • Princess Alexandra Hospital, Brisbane, Australia

    collaborator OTHER
  • Loewenstein Hospital

    lead OTHER

Principal Investigators

  • Arie Oksenberg, PhD · Loewenstein Hospital - Rehabilitation Center, Raanana, Israel

  • Juha Töyräs, PhD · University of Eastern Finland

Eligibility

Min Age
16 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Australia
  • Finland
  • Israel

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03232658 on ClinicalTrials.gov