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Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA

Primary Purpose

Obstructive Sleep Apnoea

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CPAP therapy withdrawal
Continue CPAP treatment
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnoea

Eligibility Criteria

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

Inclusion criteria:

  • Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI, =4% dips) of >20/h and an ESS of >10.
  • Currently >20/h oxygen desaturations (=4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
  • Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI<10 with treatment (according to CPAP machine download data).
  • Current ESS <10.

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.
  • Age <20 or >75 years at trial entry.
  • Acute inflammatory disease

Sites / Locations

  • University Hospital Zurich, Division of Pneumology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo CPAP

therapeutic CPAP

Arm Description

patients established on CPAP therapy, who are randomized to the placebo comparator, will use a CPAP device with subtherapeutic pressure during two weeks.

patients who are randomized to the active comparator, will continue with CPAP treatment with therapeutic pressure during two weeks

Outcomes

Primary Outcome Measures

hyperaemic myocardial blood flow

Secondary Outcome Measures

Coronary flow reserve
Coronary flow reserve determined by PET
Urine albumine excretion rate
Dermal microvascular vasodilatory response

Full Information

First Posted
February 15, 2013
Last Updated
December 20, 2013
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01797653
Brief Title
Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA
Official Title
The Effects of CPAP-withdrawal on Microvascular Function in Patients With Obstructive Sleep Apnea: A Randomized-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with obstructive sleep apnea (OSA) to define the physiological effects of continuous positive airway pressure (CPAP) therapy withdrawal on myocardial perfusion and dermal and renal microvascular function during a 2 week period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo CPAP
Arm Type
Placebo Comparator
Arm Description
patients established on CPAP therapy, who are randomized to the placebo comparator, will use a CPAP device with subtherapeutic pressure during two weeks.
Arm Title
therapeutic CPAP
Arm Type
Active Comparator
Arm Description
patients who are randomized to the active comparator, will continue with CPAP treatment with therapeutic pressure during two weeks
Intervention Type
Other
Intervention Name(s)
CPAP therapy withdrawal
Other Intervention Name(s)
CPAP treatment with subtherapeutic pressure
Intervention Description
CPAP (continuous positive airway pressure) with subtherapeutic pressure during two weeks
Intervention Type
Procedure
Intervention Name(s)
Continue CPAP treatment
Other Intervention Name(s)
therapeutic continuous positive airway pressure device
Intervention Description
Continue treatment with therapeutic continuous positive airway pressure device
Primary Outcome Measure Information:
Title
hyperaemic myocardial blood flow
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Coronary flow reserve
Description
Coronary flow reserve determined by PET
Time Frame
2 weeks
Title
Urine albumine excretion rate
Time Frame
2 weeks
Title
Dermal microvascular vasodilatory response
Time Frame
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: Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI, =4% dips) of >20/h and an ESS of >10. Currently >20/h oxygen desaturations (=4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP. Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI<10 with treatment (according to CPAP machine download data). Current ESS <10. 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. Age <20 or >75 years at trial entry. Acute inflammatory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm Kohler, Prof MD
Organizational Affiliation
University Hospital Zurich, Division of Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Pneumology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29700104
Citation
Schwarz EI, Furian M, Schlatzer C, Stradling JR, Kohler M, Bloch KE. Nocturnal cerebral hypoxia in obstructive sleep apnoea: a randomised controlled trial. Eur Respir J. 2018 May 30;51(5):1800032. doi: 10.1183/13993003.00032-2018. Print 2018 May.
Results Reference
derived
PubMed Identifier
27860068
Citation
Turnbull CD, Rossi VA, Santer P, Schwarz EI, Stradling JR, Petousi N, Kohler M. Effect of OSA on hypoxic and inflammatory markers during CPAP withdrawal: Further evidence from three randomized control trials. Respirology. 2017 May;22(4):793-799. doi: 10.1111/resp.12946. Epub 2016 Nov 18.
Results Reference
derived
PubMed Identifier
27452767
Citation
Schwarz EI, Schlatzer C, Rossi VA, Stradling JR, Kohler M. Effect of CPAP Withdrawal on BP in OSA: Data from Three Randomized Controlled Trials. Chest. 2016 Dec;150(6):1202-1210. doi: 10.1016/j.chest.2016.07.012. Epub 2016 Jul 21.
Results Reference
derived
PubMed Identifier
26022961
Citation
Stradling JR, Schwarz EI, Schlatzer C, Manuel AR, Lee R, Antoniades C, Kohler M. Biomarkers of oxidative stress following continuous positive airway pressure withdrawal: data from two randomised trials. Eur Respir J. 2015 Oct;46(4):1065-71. doi: 10.1183/09031936.00023215. Epub 2015 May 28.
Results Reference
derived

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Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA

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