Breath Analysis in Obstructive Sleep Apnoea

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Zurich
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich
ClinicalTrials.gov Identifier:
NCT02050425
First received: January 28, 2014
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnoea (OSA)
Device: Placebo-CPAP device
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Exhaled breath pattern. [ Time Frame: at baseline and at follow-up (2 weeks) ] [ Designated as safety issue: No ]
    OSA-specific mass spectrometric exhaled breath pattern.


Secondary Outcome Measures:
  • apnoea-hypopnoea index (AHI) [ Time Frame: at baseline and at follow-up (2 weeks) ] [ Designated as safety issue: No ]
    measure of sleep apnoea severity

  • oxygen desaturation index (ODI), 4% dips [ Time Frame: at baseline and at follow-up (2 weeks) ] [ Designated as safety issue: No ]
    measure of sleep apnoea severity


Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Therapeutic CPAP
Patients continue therapeutic continuous positive airway pressure (CPAP).
Device: CPAP
Patients continue therapeutic CPAP therapy
Placebo Comparator: Subtherapeutic CPAP
Placebo-CPAP device delivering subtherapeutic pressure for two weeks.
Device: Placebo-CPAP device
short-term CPAP withdrawal by the use of Placebo-CPAP
Other Name: subtherapeutic CPAP

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050425

Contacts
Contact: Malcolm Kohler, Prof. MD +41442551111 malcolm.kohler@usz.ch
Contact: Esther I Schwarz, MD +41442551111 estherirene.schwarz@usz.ch

Locations
Switzerland
Division of Pulmonology, University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Malcolm Kohler, Prof. MD    +4144255111    malcolm.kohler@usz.ch   
Contact: Esther I Schwarz, MD    +4144255111    estherirene.schwarz@usz.ch   
Principal Investigator: Malcolm Kohler, Prof. MD         
Sub-Investigator: Esther I Schwarz, MD         
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
  More Information

No publications provided

Responsible Party: Malcolm Kohler, Prof. Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT02050425     History of Changes
Other Study ID Numbers: KEK-2013-0536
Study First Received: January 28, 2014
Last Updated: January 29, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
OSA
CPAP
exhaled breath

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014