NCT02047071

Brief Summary

The purpose of this study is to determine whether Continuous Positive Airways Pressure (CPAP) improves quality of life, cardiovascular (blood pressure) and metabolic profile (glucose and lipid metabolism) in females with moderate-to-severe Obstructive Sleep Apnea (OSA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

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

January 19, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

January 19, 2014

Last Update Submit

August 17, 2015

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaFemale genderContinuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in quality of life on the Quebec Sleep Questionnaire (QSQ) at week 12

    Baseline, 12 weeks.

Secondary Outcomes (9)

  • Change from baseline in quality of life on the 12-Item Short Form Health Survey (SF-12) at week 12

    baseline, 12 weeks

  • Change from baseline in mood state on the Abbreviated Profile Of Mood States (POMS) at week 12

    Baseline, 12 weeks

  • Change from baseline in sleepiness on the Epworth Sleepiness Score (ESS) at week 12

    baseline, 12 weeks

  • Change from baseline in anxiety and depression on the Hospital Anxiety and Depression questionnaire (HAD) at week 12

    baseline, 12 weeks

  • Change from baseline in quality of life on the Visual Analogic Scale (VAS) at week 12

    baseline, 12 weeks

  • +4 more secondary outcomes

Other Outcomes (1)

  • Number of Participants with CPAP use >= 4 hours/day as a Measure of CPAP adherence

    Baseline, 12 weeks

Study Arms (2)

Standard Care

NO INTERVENTION

Conservative treatment. This group will be receive standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling.

Continuous positive airways pressure

EXPERIMENTAL

Optimal Continuous positive airways pressure treatment every night plus standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling.

Device: Continuous positive airways pressure

Interventions

Continuous positive airways pressureDEVICE

Optimal Continuous positive airways pressure treatment every night plus standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling.

Continuous positive airways pressure

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate-to-severe OSA (Apnea-Hypopnea index ≥15) diagnosed by Home Respiratory Polygraphy.
  • Age between 18-75 years.

You may not qualify if:

  • diagnosis of narcolepsy or restless legs syndrome
  • unstable cardiovascular profile (cardiovascular event in the previous 3 months)
  • cancer or life expectancy lower than 1 year
  • uncontrolled psychiatric disorders
  • central sleep apnea (\>50% of central events)
  • pregnancy
  • risky jobs and severe hypersomnolence (Epworth \>=18) requiring urgent treatment
  • either respiratory failure (SaO2\<90% or partial oxygen pressure \[pO2\] \<60 mmHg or Long-term O2 therapy
  • heart failure (New York Heart Association class III-IV)
  • prior CPAP therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Valme

Seville, 41014, Spain

Location

Related Publications (3)

  • Campos-Rodriguez F, Asensio-Cruz MI, Cordero-Guevara J, Jurado-Gamez B, Carmona-Bernal C, Gonzalez-Martinez M, Troncoso MF, Sanchez-Lopez V, Arellano-Orden E, Garcia-Sanchez MI, Martinez-Garcia MA; Spanish Sleep Network. Effect of continuous positive airway pressure on inflammatory, antioxidant, and depression biomarkers in women with obstructive sleep apnea: a randomized controlled trial. Sleep. 2019 Oct 9;42(10):zsz145. doi: 10.1093/sleep/zsz145.

    PMID: 31314107DERIVED

  • Campos-Rodriguez F, Gonzalez-Martinez M, Sanchez-Armengol A, Jurado-Gamez B, Cordero-Guevara J, Reyes-Nunez N, Troncoso MF, Abad-Fernandez A, Teran-Santos J, Caballero-Rodriguez J, Martin-Romero M, Encabo-Motino A, Sacristan-Bou L, Navarro-Esteva J, Somoza-Gonzalez M, Masa JF, Sanchez-Quiroga MA, Jara-Chinarro B, Orosa-Bertol B, Martinez-Garcia MA; Spanish Sleep Network. Effect of continuous positive airway pressure on blood pressure and metabolic profile in women with sleep apnoea. Eur Respir J. 2017 Aug 10;50(2):1700257. doi: 10.1183/13993003.00257-2017. Print 2017 Aug.

    PMID: 28798089DERIVED

  • Campos-Rodriguez F, Queipo-Corona C, Carmona-Bernal C, Jurado-Gamez B, Cordero-Guevara J, Reyes-Nunez N, Troncoso-Acevedo F, Abad-Fernandez A, Teran-Santos J, Caballero-Rodriguez J, Martin-Romero M, Encabo-Motino A, Sacristan-Bou L, Navarro-Esteva J, Somoza-Gonzalez M, Masa JF, Sanchez-Quiroga MA, Jara-Chinarro B, Orosa-Bertol B, Martinez-Garcia MA; Spanish Sleep Network. Continuous Positive Airway Pressure Improves Quality of Life in Women with Obstructive Sleep Apnea. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2016 Nov 15;194(10):1286-1294. doi: 10.1164/rccm.201602-0265OC.

    PMID: 27181196DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Francisco Campos-Rodriguez, MD

    Sociedad Española de Neumología y Cirugía Torácica

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 19, 2014

First Posted

January 28, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

ES(1)