Sleep Apnea SyndromesPhase 4SAHS2-3NCT02398032
CPAP in SAHS Patients With Hypertension
A Phase 4 study testing CPAP nasal in people with Sleep Apnea Syndromes and Hypertension, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP) effect on these parameters. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea Syndromes, Hypertension
- What is being tested?
- CPAP nasal
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- May 2013to Mar 2016
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent diagnosis of sleep apnea-hypopnea syndrome with an apnea-hypopnea index (AHI) > 10 h-1
- No previous treatment for SAHS or hypertension
- Diagnosis by 24-h ambulatory monitoring of blood pressure (AMBP) of isolated nocturnal hypertension (nighttime blood pressure of ≥120 mm Hg systolic or 70 mm Hg diastolic and a daytime blood pressure <135/85 mm Hg) or day-night sustained hypertension (nighttime blood pressure of ≥120 mm Hg or 70 mm Hg diastolic and a daytime blood pressure of ≥135 mm Hg systolic).
Who cannot join
- Severe hypertension (> 180/120 mmHg).
- Previous diagnosis of secondary hypertension.
- Myocardial infarction or stroke in the last three months.
- Severe diurnal sleepiness (Epworth score > 15)
- Previous diagnosis of chronic obstructive pulmonary disease, asthma, bronchiectasis, lung cancer, restrictive lung disease, chest wall disease or thoracic surgery.
- Previous diagnosis or clinical evidence of heart disease, neuromuscular disease or thyroid dysfunction.
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- Morbid obesity (BMI > 40 Kg/m2)
- Respiratory infection in the last two months.
- Treatment with theophylline or systemic corticosteroids in the last two years.
- Excessive alcohol intake (>40 g/day)
- Absence of social or familiar support.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CPAP Effect on Nocturnal Evolution of Chemosensitivity Determinants in Sleep Apnea-hypopnea Patients With Isolated Nocturnal Hypertension or Day-nigh Sustained Hypertension
Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP) effect on these parameters.
Design: Controlled cross-over longitudinal study. Settings: Madrid metropolitan area. Patients: Day-night sustained hypertensive and isolated nocturnal hypertensive patients with SAHS without previous treatment. At least 30 patients are needed.
Read more
Interventions: Patients will allocate in each treatment arm (CPAP vs. sham CPAP) during three months. Explorations will perform before and immediately after sleep at 0-, 3-, and 6-months of trial.
Measurements: 24-h urinary catecholamine, local vascular factors, angiotensin and aldosterone levels. Diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal test, and ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia.
- Conditions
- Sleep Apnea Syndromes, Hypertension
- Being tested
- CPAP nasal, sham CPAP nasal
- Keywords
- sleep apnea, hypertension, mechanosensitivity, chemosensitivity, adhesion factors
- Medical subject headings
- Sleep Apnea Syndromes, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP nasalDevice
Also called Nocturnal support with continuous positive airway pressure
During the night
sham CPAP nasalDevice
Also called sham CPAP
During the night
| Study group | Role | What they receive |
|---|---|---|
| CPAP nasal | Experimental | Nasal continuous positive airway pressure, during the night Receives: Device: CPAP nasal |
| sham CPAP nasal | Sham comparator | Nasal sham continuous positive airway pressure, during the night Receives: Device: sham CPAP nasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of CPAP on the night-morning change in the withdrawal response and in the ventilatory and central drive responses to progressive isocapnic hypoxia.
To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the withdrawal response (decrease in ventilation caused by two breaths of 100% oxygen, %ΔV'I) and in the ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia (ΔV'I/arterial oxygen saturation (SaO2)/body surface area (BSA)] and Δ occlusion pressure at 0.1 s (P0.1)/arterial oxygen saturation (SaO2), respectively).
Measured: 3 months
Secondary outcomes (4)
CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index
To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the sniff diaphragmatic tension-time index (TTdi)
Measured: 3 months
CPAP effect on blood pressure
To compare the effect of three months of CPAP therapy on the blood pressure in SAHS patients with isolated nocturnal hypertension and SAHS patients with day-nigh sustained hypertension
Measured: 3 months
CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1
To compare the effect of three months of CPAP therapy versus sham CPAP on the serum levels of endothelin-1 and VCAM-1 in SAHS patients with isolated nocturnal hypertension and SAHS patients with day-nigh sustained hypertension
Measured: 3 months
CPAP effect on the night-morning change in the rest metabolic rate
To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the rest metabolic rate (carbon dioxide production/oxygen uptake ratio, RER)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMay 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Garcia-Rio, Hospital Universitario La Paz
- Investigators
- Francisco Garcia-Rio, MD, Principal investigator, Hospital Universitario La Paz, IdiPAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398032
- Sponsor's protocol ID
- 99/0252
- Acronym
- SAHS2-3
- Status last verified
- May 2016
- First submitted
- 1 Apr 2013
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Casitas R, Martinez-Ceron E, Galera R, Cubillos-Zapata C, Gonzalez-Villalba MJ, Fernandez-Navarro I, Sanchez B, Garcia-Sanchez A, Zamarron E, Garcia-Rio F. The effect of treatment for sleep apnoea on determinants of blood pressure control. Eur Respir J. 2017 Nov 16;50(5):1701261. doi: 10.1183/13993003.01261-2017. Print 2017 Nov.
PubMed 29146604
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Effect on Nocturnal Evolution of Chemosensitivity Determinants in Sleep Apnea-hypopnea Patients With Isolated Nocturnal Hypertension or Day-nigh Sustained Hypertension
- ClinicalTrials.gov ID
- NCT02398032
- Acronym / sponsor ID
- SAHS2-3 / 99/0252
- Conditions
- Sleep Apnea Syndromes, Hypertension
- Keywords
- sleep apnea, hypertension, mechanosensitivity, chemosensitivity, adhesion factors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Mar 2015 (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.
Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP) effect on these parameters.
Design: Controlled cross-over longitudinal study. Settings: Madrid metropolitan area. Patients: Day-night sustained hypertensive and isolated nocturnal hypertensive patients with SAHS without previous treatment. At least 30 patients are needed.
Interventions: Patients will allocate in each treatment arm (CPAP vs. sham CPAP) during three months. Explorations will perform before and immediately after sleep at 0-, 3-, and 6-months of trial.
Measurements: 24-h urinary catecholamine, local vascular factors, angiotensin and aldosterone levels. Diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal test, and ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP nasal | Experimental | Device: CPAP nasalNasal continuous positive airway pressure, during the night |
| sham CPAP nasal | Sham comparator | Device: sham CPAP nasalNasal sham continuous positive airway pressure, during the night |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recent diagnosis of sleep apnea-hypopnea syndrome with an apnea-hypopnea index (AHI) > 10 h-1
- No previous treatment for SAHS or hypertension
- Diagnosis by 24-h ambulatory monitoring of blood pressure (AMBP) of isolated nocturnal hypertension (nighttime blood pressure of ≥120 mm Hg systolic or 70 mm Hg diastolic and a daytime blood pressure <135/85 mm Hg) or day-night sustained hypertension (nighttime blood pressure of ≥120 mm Hg or 70 mm Hg diastolic and a daytime blood pressure of ≥135 mm Hg systolic).
Key exclusion criteria (11 listed)
- Severe hypertension (> 180/120 mmHg).
- Previous diagnosis of secondary hypertension.
- Myocardial infarction or stroke in the last three months.
- Severe diurnal sleepiness (Epworth score > 15)
- Previous diagnosis of chronic obstructive pulmonary disease, asthma, bronchiectasis, lung cancer, restrictive lung disease, chest wall disease or thoracic surgery.
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 |
|---|---|---|
| CPAP nasalAlso: Nocturnal support with continuous positive airway pressureDuring the night | Device | CPAP nasal |
| sham CPAP nasalAlso: sham CPAPDuring the night | Device | sham CPAP nasal |
Primary outcome
Effect of CPAP on the night-morning change in the withdrawal response and in the ventilatory and central drive responses to progressive isocapnic hypoxia.
Time frame: 3 months
To compare the effect of three months of CPAP therapy versus sham CPAP on the night-morning (pre- vs. post-sleep) change in the withdrawal response (decrease in ventilation caused by two breaths of 100% oxygen, %ΔV'I) and in the ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia (ΔV'I/arterial oxygen saturation (SaO2)/body surface area (BSA)] and Δ occlusion pressure at 0.1 s (P0.1)/arterial oxygen saturation (SaO2), respectively).
4 secondary outcomes
CPAP effect on the night-morning change in the sniff diaphragmatic tension-time index
Time frame: 3 months
CPAP effect on blood pressure
Time frame: 3 months
CPAP effect on the serum levels of endothelin-1 and vascular endothelial cell adhesion molecule (VCAM)-1
Time frame: 3 months
CPAP effect on the night-morning change in the rest metabolic rate
Time frame: 3 months
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 3 May 2016.
- Derived from this study: PubMed 29146604Casitas R, Martinez-Ceron E, Galera R, Cubillos-Zapata C, Gonzalez-Villalba MJ, Fernandez-Navarro I, Sanchez B, Garcia-Sanchez A, Zamarron E, Garcia-Rio F. The effect of treatment for sleep apnoea on determinants of blood pressure control. Eur Respir J. 2017 Nov 16;50(5):1701261. doi: 10.1183/13993003.01261-2017. Print 2017 Nov.
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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 Garcia-Rio, MD principal investigator
Hospital Universitario La Paz, IdiPAZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP nasal in people with Sleep Apnea Syndromes and Hypertension, run by Hospital Universitario La Paz 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 3 inclusion and 11 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 3 May 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of CPAP on the night-morning change in the withdrawal response and in the ventilatory and central drive responses to progressive isocapnic hypoxia. (time frame: 3 months). 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 NCT02398032, which also lists 1 linked publication.
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 3 May 2016.