NCT02050425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

9 months

First QC Date

January 28, 2014

Last Update Submit

November 23, 2014

Conditions

Obstructive Sleep Apnoea (OSA)

Keywords

OSACPAPexhaled breath

Outcome Measures

Primary Outcomes (1)

  • Exhaled breath pattern.

    OSA-specific mass spectrometric exhaled breath pattern.

    at baseline and at follow-up (2 weeks)

Secondary Outcomes (2)

  • apnoea-hypopnoea index (AHI)

    at baseline and at follow-up (2 weeks)

  • oxygen desaturation index (ODI), 4% dips

    at baseline and at follow-up (2 weeks)

Study Arms (2)

Therapeutic CPAP

ACTIVE COMPARATOR

Patients continue therapeutic continuous positive airway pressure (CPAP).

Device: CPAP

Subtherapeutic CPAP

PLACEBO COMPARATOR

Placebo-CPAP device delivering subtherapeutic pressure for two weeks.

Device: Placebo-CPAP device

Interventions

Placebo-CPAP deviceDEVICE

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

Also known as: subtherapeutic CPAP
Subtherapeutic CPAP
CPAPDEVICE

Patients continue therapeutic CPAP therapy

Therapeutic CPAP

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Pulmonology, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 31467191DERIVED

  • 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.

    PMID: 28548301DERIVED

  • 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.

    PMID: 26671307DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

CH(1)