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

NCT01797653 | Completed

• 1 other identifier: CPAP_V1.0 (01.11.2012)
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnoea

Outcome Measures

Primary Outcomes (1)

• hyperaemic myocardial blood flow

  2 weeks

Secondary Outcomes (3)

• Coronary flow reserve

  2 weeks

• Urine albumine excretion rate

  2 weeks

• Dermal microvascular vasodilatory response

  2 weeks

Study Arms (2)

Placebo CPAP

PLACEBO COMPARATOR

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

Other: CPAP therapy withdrawal

therapeutic CPAP

ACTIVE COMPARATOR

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

Procedure: Continue CPAP treatment

Interventions

CPAP therapy withdrawal OTHER

CPAP (continuous positive airway pressure) with subtherapeutic pressure during two weeks

Also known as: CPAP treatment with subtherapeutic pressure

Placebo CPAP

Continue CPAP treatment PROCEDURE

Continue treatment with therapeutic continuous positive airway pressure device

Also known as: therapeutic continuous positive airway pressure device

therapeutic CPAP

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Pneumology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 29700104 DERIVED

• 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.

  PMID: 27860068 DERIVED

• 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.

  PMID: 27452767 DERIVED

• 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.

  PMID: 26022961 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Malcolm Kohler, Prof MD

  University Hospital Zurich, Division of Pneumology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 22, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

CH (1)