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Breath Analysis in Obstructive Sleep Apnoea

NCT ID: NCT02050425

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnoea (OSA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Therapeutic CPAP

Patients continue therapeutic continuous positive airway pressure (CPAP).

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

Patients continue therapeutic CPAP therapy

Subtherapeutic CPAP

Placebo-CPAP device delivering subtherapeutic pressure for two weeks.

Group Type PLACEBO_COMPARATOR

Placebo-CPAP device

Intervention Type DEVICE

short-term CPAP withdrawal by the use of Placebo-CPAP

Interventions

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Placebo-CPAP device

short-term CPAP withdrawal by the use of Placebo-CPAP

Intervention Type DEVICE

CPAP

Patients continue therapeutic CPAP therapy

Intervention Type DEVICE

Other Intervention Names

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subtherapeutic CPAP

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Malcolm Kohler

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Pulmonology, University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 31467191 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28548301 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26671307 (View on PubMed)

Other Identifiers

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KEK-2013-0536

Identifier Type: -

Identifier Source: org_study_id