NCT02057783

Brief Summary

Investigators hypothesize that CPAP treatment for suppressing OSAS in combination with a physical activity program will optimize 24-hour blood pressure control in patients with OSA-related resistant hypertension.

Trial Health

60
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

February 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 26, 2015

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

9.9 years

First QC Date

February 4, 2014

Last Update Submit

February 18, 2025

Conditions

Hypertension, Resistant to Conventional TherapySleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

    Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

    To baseline at 12 weeks

Secondary Outcomes (7)

  • diastolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

    To baseline at 12 weeks

  • Mean arterial blood pressure assessed by 24-hours home blood pressure monitoring

    To baseline at 12 weeks

  • Change in physical activity: number of hour per day of physical activity

    To baseline at 12 weeks

  • pulse wave velocity

    To baseline at 12 weeks

  • Change in physical activity : Metabolic Equivalents (METS)

    To baseline at 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Physical activity

EXPERIMENTAL

Obstructive sleep apnea and resistant hypertension controlled + physical activity

Other: Physical activity

Control Group

NO INTERVENTION

Obstructive sleep apnea and resistant hypertension controlled

Interventions

Physical activityOTHER

Physical activity will carry out 3 times per week during 12 weeks for intervention arm

Physical activity

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with an obstructive sleep apnea (apnea-hypopnea index \> or equal to 15)
  • Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents
  • Ambulatory patient

You may not qualify if:

  • Acute hepatic failure, biliary cirrhosis, cholestasis
  • Acute hypertension (SBP\>= 180 mmHg and/or DBP \>= 110 mmHg)
  • Contraindication to CPAP treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Canada

RECRUITING

Hopital Universitaire de Grenoble

La Tronche, 38700, France

RECRUITING

Clinique Pasteur

Toulouse, 31300, France

RECRUITING

Hopitaux Universitaires de Genève

Geneva, Switzerland

WITHDRAWN

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

WITHDRAWN

MeSH Terms

Conditions

Hypertension Resistant to Conventional TherapySleep Apnea Syndromes

Interventions

Exercise

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jean-Louis Pépin, Pr MD PhD

    Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Louis Pépin, Pr MD PhD

CONTACT

JPepin@chu-grenoble.fr

Sandrine Bouzon

CONTACT

sbouzon@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 7, 2014

Study Start

March 26, 2015

Primary Completion

February 18, 2025

Study Completion

February 18, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations

FR(2)CA(1)CH(2)