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Breath Analysis in Obstructive Sleep Apnoea

Primary Purpose

Obstructive Sleep Apnoea (OSA)

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Placebo-CPAP device
CPAP
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnoea (OSA) focused on measuring OSA, CPAP, exhaled breath

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h.
  • Currently >20/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP.
  • Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP- download) and current ESS <10.
  • Age between 20 and 75 years at trial entry.

Exclusion Criteria:

  • Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa).
  • Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
  • Previously diagnosed with Cheyne-Stokes breathing.
  • Current professional driver; any previous sleep related accident.
  • Acute inflammatory disease.
  • Acute or chronic hepatic disease.
  • Renal failure or renal replacement therapy.
  • Use of inhaled drugs.

Sites / Locations

  • Division of Pulmonology, University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Therapeutic CPAP

Subtherapeutic CPAP

Arm Description

Patients continue therapeutic continuous positive airway pressure (CPAP).

Placebo-CPAP device delivering subtherapeutic pressure for two weeks.

Outcomes

Primary Outcome Measures

Exhaled breath pattern.
OSA-specific mass spectrometric exhaled breath pattern.

Secondary Outcome Measures

apnoea-hypopnoea index (AHI)
measure of sleep apnoea severity
oxygen desaturation index (ODI), 4% dips
measure of sleep apnoea severity

Full Information

First Posted
January 28, 2014
Last Updated
November 23, 2014
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02050425
Brief Title
Breath Analysis in Obstructive Sleep Apnoea
Official Title
Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry.
Detailed Description
Randomised placebo-controlled trial (therapeutic vs. subtherapeutic continuous positive airway pressure [CPAP]) including 30 OSA patients to define the effects of CPAP withdrawal (subtherapeutic CPAP) on the composition of exhaled breath analysed by mass spectrometry for identification of OSA specific markers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea (OSA)
Keywords
OSA, CPAP, exhaled breath

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic CPAP
Arm Type
Active Comparator
Arm Description
Patients continue therapeutic continuous positive airway pressure (CPAP).
Arm Title
Subtherapeutic CPAP
Arm Type
Placebo Comparator
Arm Description
Placebo-CPAP device delivering subtherapeutic pressure for two weeks.
Intervention Type
Device
Intervention Name(s)
Placebo-CPAP device
Other Intervention Name(s)
subtherapeutic CPAP
Intervention Description
short-term CPAP withdrawal by the use of Placebo-CPAP
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Patients continue therapeutic CPAP therapy
Primary Outcome Measure Information:
Title
Exhaled breath pattern.
Description
OSA-specific mass spectrometric exhaled breath pattern.
Time Frame
at baseline and at follow-up (2 weeks)
Secondary Outcome Measure Information:
Title
apnoea-hypopnoea index (AHI)
Description
measure of sleep apnoea severity
Time Frame
at baseline and at follow-up (2 weeks)
Title
oxygen desaturation index (ODI), 4% dips
Description
measure of sleep apnoea severity
Time Frame
at baseline and at follow-up (2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h. Currently >20/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP. Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP- download) and current ESS <10. Age between 20 and 75 years at trial entry. Exclusion Criteria: Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa). Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg) Previously diagnosed with Cheyne-Stokes breathing. Current professional driver; any previous sleep related accident. Acute inflammatory disease. Acute or chronic hepatic disease. Renal failure or renal replacement therapy. Use of inhaled drugs.
Facility Information:
Facility Name
Division of Pulmonology, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31467191
Citation
Thiel S, Haile SR, Peitzsch M, Schwarz EI, Sievi NA, Kurth S, Beuschlein F, Kohler M, Gaisl T. Endocrine responses during CPAP withdrawal in obstructive sleep apnoea: data from two randomised controlled trials. Thorax. 2019 Nov;74(11):1102-1105. doi: 10.1136/thoraxjnl-2019-213522. Epub 2019 Aug 29.
Results Reference
derived
PubMed Identifier
28548301
Citation
Stoberl AS, Schwarz EI, Haile SR, Turnbull CD, Rossi VA, Stradling JR, Kohler M. Night-to-night variability of obstructive sleep apnea. J Sleep Res. 2017 Dec;26(6):782-788. doi: 10.1111/jsr.12558. Epub 2017 May 26.
Results Reference
derived
PubMed Identifier
26671307
Citation
Schwarz EI, Martinez-Lozano Sinues P, Bregy L, Gaisl T, Garcia Gomez D, Gaugg MT, Suter Y, Stebler N, Nussbaumer-Ochsner Y, Bloch KE, Stradling JR, Zenobi R, Kohler M. Effects of CPAP therapy withdrawal on exhaled breath pattern in obstructive sleep apnoea. Thorax. 2016 Feb;71(2):110-7. doi: 10.1136/thoraxjnl-2015-207597. Epub 2015 Dec 15.
Results Reference
derived

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Breath Analysis in Obstructive Sleep Apnoea

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