NCT02273089

Brief Summary

This study intends to determine whether continuous positive airway pressure (CPAP) can reduce arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in sleepy patients with obstructive sleep apnea .

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

October 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

4.2 years

First QC Date

October 6, 2014

Last Update Submit

July 11, 2017

Conditions

Obstructive Sleep ApneaVascular StiffnessSleep Disorder Daytime Somnolence

Keywords

Obstructive sleep apneaarterial stiffnessCPAPexcessive daytime sleepinesspulse wave velocity

Outcome Measures

Primary Outcomes (1)

  • Aortic pulse wave velocity (PWV)

    carotid-femoral (aortic) pulse wave velocity (PWV) measured by noninvasive piezo-electronic system with Complior(R) (Colson, France).

    Change on PWV from baseline up to three months of intervention

Secondary Outcomes (3)

  • Apnea-Hypopnea Index (AHI)

    Change on AHI from baseline up to three months of intervention

  • Nocturnal oxygenation

    Change from baseline up to three months of intervention

  • Excessive daytime sleepiness

    Change on ESS from baseline up to three months of intervention

Other Outcomes (2)

  • Lipidic profile

    Change from baseline up to three months of intervention

  • Glucidic profile

    Change from baseline up to three months of intervention

Study Arms (2)

OSA w/o EDS

Males with moderate to severe obstructive sleep apnea without excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months

Device: CPAP (ResMed S9 AutoSet)

OSA w EDS

Males with moderate to severe obstructive sleep apnea with excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months

Device: CPAP (ResMed S9 AutoSet)

Interventions

CPAP (ResMed S9 AutoSet)DEVICE

nocturnal CPAP for three months

OSA w EDSOSA w/o EDS

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with moderate to severe obstructive sleep apnea, with or without excessive daytime sleepiness

You may qualify if:

  • moderate to severe obstructive sleep apnea, defined as apnea/hypopnea index superior to 15

You may not qualify if:

  • Epworth sleep scale superior to 16
  • other sleep diseases
  • moderate or severe lung disease
  • cardiac disease other than hypertension
  • cerebrovascular diseases
  • other vascular diseases
  • other chronic diseases except metabolic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Consulta de Sono, Departamento de Pneumologia, Centro Hospitalar de Lisboa Central

Lisbon, 1169-024, Portugal

Location

Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central

Lisbon, 1169-024, Portugal

Location

Related Publications (2)

  • Mineiro MA, Silva PMD, Alves M, Papoila AL, Marques Gomes MJ, Cardoso J. The role of sleepiness on arterial stiffness improvement after CPAP therapy in males with obstructive sleep apnea: a prospective cohort study. BMC Pulm Med. 2017 Dec 8;17(1):182. doi: 10.1186/s12890-017-0518-z.

    PMID: 29221483DERIVED

  • Mineiro MA, Marques da Silva P, Alves M, Virella D, Marques Gomes MJ, Cardoso J. Use of CPAP to reduce arterial stiffness in moderate-to-severe obstructive sleep apnoea, without excessive daytime sleepiness (STIFFSLEEP): an observational cohort study protocol. BMJ Open. 2016 Jul 12;6(7):e011385. doi: 10.1136/bmjopen-2016-011385.

    PMID: 27406645DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDisorders of Excessive Somnolence

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Alexandra Mineiro, MD

    Centro Hospitalar de Lisboa Central

    PRINCIPAL INVESTIGATOR

  • Pedro Marques-da-Silva, MD

    Centro Hospitalar de Lisboa Central

    STUDY CHAIR

  • João Cardoso, MD

    Centro Hospitalar de Lisboa Central

    STUDY CHAIR

  • Maria João Marques-Gomes, MD, PhD

    Universidade Nova de Lisboa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 23, 2014

Study Start

October 1, 2012

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

PT(2)