NCT01044355

Brief Summary

The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA). The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two CPAP modalities in order to identify which device is better for each subject.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

4.1 years

First QC Date

January 6, 2010

Last Update Submit

March 20, 2018

Conditions

Resistant HypertensionObstructive Sleep Apnea

Keywords

Resistant HypertensionObstructive Sleep Apnea24 Hour Blood PressureArterial StiffnessInsulin ResistanceCPAPAPAP

Outcome Measures

Primary Outcomes (1)

  • 24 hour blood pressure.

    6 weeks and 12 weeks after initial intervention

Secondary Outcomes (3)

  • Non-invasive measures of arterial stiffness using applanation tonometry.

    6 weeks and 12 weeks after initial intervention

  • Standard measures of OSA severity, including AHI and measures of nocturnal oxygenation and sleep quality using polysomnography.

    6 weeks and 12 weeks after initial intervention

  • Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin.

    6 weeks and 12 weeks after initial intervention

Study Arms (2)

auto-titrating

ACTIVE COMPARATOR

Patients being treated for 6 weeks with auto-titrating continuous airway pressure.

Device: APAP

Fixed

ACTIVE COMPARATOR

Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure.

Device: CPAP

Interventions

CPAPDEVICE

6 weeks treatment with fixed CPAP

Also known as: Continuous Positive Airway Pressure
Fixed
APAPDEVICE

6 weeks of treatment with auto-titrating positive airway pressure

Also known as: auto-titrating airway pressure
auto-titrating

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resistant Hypertension
  • Moderate Obstructive Sleep Apnea

You may not qualify if:

  • Creatinine \>150 μmol/l
  • Systolic blood pressure \> 170 mmHg
  • Diastolic blood pressure \> 105 mmHg
  • Secondary cause of hypertension other than OSA
  • Treatment within the last 3 months or current treatment for sleep-disordered breathing or some other sleep disorder
  • Current treatment or recent treatment within the last 3 months for any other medical condition which has resulted or would be expected to result in a change in blood pressure medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveInsulin Resistance

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Stella S Daskalopoulou, MD, MSc, PHd

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

  • R John Kimoff, MD, FRCP(C)

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

December 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2020

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

CA(2)