Obstructive Sleep ApneaNCT02047071
Effect of CPAP Treatment in Women With Moderate-to-severe OSA.
A study testing Continuous positive airways pressure in people with Obstructive Sleep Apnea, run by Francisco Campos-Rodriguez at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airways pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate-to-severe OSA (Apnea-Hypopnea index ≥15) diagnosed by Home Respiratory Polygraphy.
- Age between 18-75 years.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Positive Airways Pressure (CPAP) in Women With Moderate-to-severe Obstructive Sleep Apnea (OSA). A Multicenter, Randomized, Controlled Trial.
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).
Read the detailed description
Study Design: multicenter, open-label, randomized, controlled trial of parallel groups with a final blind evaluation.
Study sites. The following hospitals will participate in the study: Valme (Sevilla), la Fe (Valencia), Virgen del Rocío (Sevilla), Gral Yagüe (Burgos), San Pedro de Alcántara (Cáceres), Dr Peset (Valencia), Severo Ochoa (Madrid), Reina Sofía (Córdoba), Dr Negrín (Las Palmas de Gran Canaria), Virgen de la Victoria (Málaga), Río Hortega (Valladolid), Costa del Sol (Málaga), Marqués de Valdecilla (Santander), Albacete (Albacete), Virgen del Puerto (Cáceres), Puerta de Hierro (Madrid), Consorcio Sanitario de Terrassa (Barcelona), Getafe (Madrid), Gral de Alicante (Alicante), Morales Meseguer (Murcia), Tomelloso (Ciudad Real), and Fundación Jiménez Díaz (Madrid). All centers from Spain.
Methods: consecutive outpatient women aged 18-75 years and referred to the sleep clinics for suspicion of OSA will be studied. They will undergo a diagnostic home respiratory polygraphy, and those diagnosed with moderate-to-severe OSA (AHI ≥15) will be eligible for this study and randomized to optimal CPAP treatment or conservative treatment for 12 weeks. Every women will fulfill a standardized protocol and different quality of life questionnaires. Office blood pressure will be measured. Fasting blood samples will be collected to assess glucose and lipid metabolism. All the measurements will be performed at baseline and after 12 weeks of follow-up. Women will be examined at the time of inclusion, after 4 weeks of follow-up and at the end of follow-up (12 weeks).
149 women with moderate-to-severe OSA need to be enrolled in each study arm, according to the sample size calculated to achieve a clinically significant improvement in the Quebec Sleep Questionnaire. The results will be analyzed both on an intention-to-treat basis and on a per-protocol basis (data only from patients who finish the study and show good adherence to CPAP, defined as an average objective use of at least 4 hours/day).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous positive airways pressure
- Keywords
- Obstructive sleep apnea, Female gender, Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous positive airways pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in quality of life on the Quebec Sleep Questionnaire (QSQ) at week 12
Measured: 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
Measured: baseline, 12 weeks
Change from baseline in mood state on the Abbreviated Profile Of Mood States (POMS) at week 12
Measured: Baseline, 12 weeks
Change from baseline in sleepiness on the Epworth Sleepiness Score (ESS) at week 12
Measured: baseline, 12 weeks
Change from baseline in anxiety and depression on the Hospital Anxiety and Depression questionnaire (HAD) at week 12
Measured: baseline, 12 weeks
Change from baseline in quality of life on the Visual Analogic Scale (VAS) at week 12
Measured: baseline, 12 weeks
Change from baseline in sleep apnea symptoms at week 12
Measured: baseline, 12 weeks
Change from baseline in blood pressure at week 12
Change in office blood pressure from baseline at week 12
Measured: Baseline, 12 weeks
Change from baseline in glucose metabolism at week 12
Measured: baseline, 12 weeks
Change from baseline in lipid metabolism at week 12
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Campos-Rodriguez
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Sponsor-investigator, Francisco Campos-Rodriguez, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Francisco Campos-Rodriguez, MD, Principal investigator, Sociedad Española de Neumología y Cirugía Torácica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047071
- Sponsor's protocol ID
- PI13/00743
- Status last verified
- Aug 2015
- First submitted
- 19 Jan 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31314107Campos-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.
PubMed 28798089Campos-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.
PubMed 27181196
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airways Pressure (CPAP) in Women With Moderate-to-severe Obstructive Sleep Apnea (OSA). A Multicenter, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02047071
- Acronym / sponsor ID
- PI13/00743
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Female gender, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Francisco Campos-RodriguezUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Sociedad Española de Neumología y Cirugía Torácica
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study Design: multicenter, open-label, randomized, controlled trial of parallel groups with a final blind evaluation.
Study sites. The following hospitals will participate in the study: Valme (Sevilla), la Fe (Valencia), Virgen del Rocío (Sevilla), Gral Yagüe (Burgos), San Pedro de Alcántara (Cáceres), Dr Peset (Valencia), Severo Ochoa (Madrid), Reina Sofía (Córdoba), Dr Negrín (Las Palmas de Gran Canaria), Virgen de la Victoria (Málaga), Río Hortega (Valladolid), Costa del Sol (Málaga), Marqués de Valdecilla (Santander), Albacete (Albacete), Virgen del Puerto (Cáceres), Puerta de Hierro (Madrid), Consorcio Sanitario de Terrassa (Barcelona), Getafe (Madrid), Gral de Alicante (Alicante), Morales Meseguer (Murcia), Tomelloso (Ciudad Real), and Fundación Jiménez Díaz (Madrid). All centers from Spain.
Methods: consecutive outpatient women aged 18-75 years and referred to the sleep clinics for suspicion of OSA will be studied. They will undergo a diagnostic home respiratory polygraphy, and those diagnosed with moderate-to-severe OSA (AHI ≥15) will be eligible for this study and randomized to optimal CPAP treatment or conservative treatment for 12 weeks. Every women will fulfill a standardized protocol and different quality of life questionnaires. Office blood pressure will be measured. Fasting blood samples will be collected to assess glucose and lipid metabolism. All the measurements will be performed at baseline and after 12 weeks of follow-up. Women will be examined at the time of inclusion, after 4 weeks of follow-up and at the end of follow-up (12 weeks).
149 women with moderate-to-severe OSA need to be enrolled in each study arm, according to the sample size calculated to achieve a clinically significant improvement in the Quebec Sleep Questionnaire. The results will be analyzed both on an intention-to-treat basis and on a per-protocol basis (data only from patients who finish the study and show good adherence to CPAP, defined as an average objective use of at least 4 hours/day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Continuous positive airways pressureOptimal Continuous positive airways pressure treatment every night plus standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate-to-severe OSA (Apnea-Hypopnea index ≥15) diagnosed by Home Respiratory Polygraphy.
- Age between 18-75 years.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airways pressureOptimal 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 |
Primary outcome
Change from baseline in quality of life on the Quebec Sleep Questionnaire (QSQ) at week 12
Time frame: Baseline, 12 weeks.
9 secondary outcomes
Change from baseline in quality of life on the 12-Item Short Form Health Survey (SF-12) at week 12
Time frame: baseline, 12 weeks
Change from baseline in mood state on the Abbreviated Profile Of Mood States (POMS) at week 12
Time frame: Baseline, 12 weeks
Change from baseline in sleepiness on the Epworth Sleepiness Score (ESS) at week 12
Time frame: baseline, 12 weeks
Change from baseline in anxiety and depression on the Hospital Anxiety and Depression questionnaire (HAD) at week 12
Time frame: baseline, 12 weeks
Change from baseline in quality of life on the Visual Analogic Scale (VAS) at week 12
Time frame: baseline, 12 weeks
Change from baseline in sleep apnea symptoms at week 12
Time frame: baseline, 12 weeks
Change from baseline in blood pressure at week 12
Time frame: Baseline, 12 weeks
Change from baseline in glucose metabolism at week 12
Time frame: baseline, 12 weeks
Change from baseline in lipid metabolism at week 12
Time frame: baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Derived from this study: PubMed 31314107Campos-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.
- Derived from this study: PubMed 28798089Campos-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.
- Derived from this study: PubMed 27181196Campos-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Campos-Rodriguez, MD principal investigator
Sociedad Española de Neumología y Cirugía Torácica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airways pressure in people with Obstructive Sleep Apnea, run by Francisco Campos-Rodriguez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in quality of life on the Quebec Sleep Questionnaire (QSQ) at week 12 (time frame: Baseline, 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02047071, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.