Obstructive Sleep ApneaPhase 2/3CPAPNCT01138865
Effect of CPAP on Biomarkers in Patients With OSA
A Phase 2/3 study testing AutoSet Spirit--Wash--Modified-AutoSet Spirit and Modified-AutoSet Spirit--Wash-AutoSet Spirit in people with Obstructive Sleep Apnea, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of cardiovascular, mortality risks in the same patients. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- AutoSet Spirit--Wash--Modified-AutoSet Spirit and Modified-AutoSet Spirit--Wash-AutoSet Spirit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2012to Mar 2015
- Phase
- Phase 2/3
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The 1st part of the study will include
- males and females, aged 30-65 years,
- with AHI >5 and excessive daytime sleepiness
- naïve to CPAP treatment.
- Subjects from first part of the study who have moderately severe OSAS and have never received treatment for OSA,diabetes mellitus and hypertension
Who cannot join
- Hypothyroidism
- Chronic renal failure
- Chronic liver disease
- Chronic lung disease
- Known systemic inflammatory diseases (lupus , sarcoidosis and other connective tissue disorders),
- Use of drugs that influence urinary protein excretion (eg. steroids, lithium, NSAIDS, ACE inhibitors/Angiotensin Receptor Blockers etc.)
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- Immune deficiency conditions
- Pregnancy
- Active menstruation at time of sampling
- Macroalbuminuria (aACR>300mg/g),
- Patients of coronary artery disease and left ventricular dysfunction
- Not on treatment for hypertension, diabetes mellitus or dyslipidemia
- Long lasting hypertension or diabetes mellitus (more than 5 years after diagnosis)
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Surendra K Sharma, MD, Ph.D, 91-11-26594415, sksharma@aiims.ac.in
Surender K Sharma, MD, Ph.D
About this study
Official title: Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.
CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of cardiovascular, mortality risks in the same patients.
Read the detailed description
Obstructive sleep apnea (OSA) is a condition in which there is collapse of the upper airway during sleep, as a result of which there is a decrease or complete cessation of airflow. This leads to repeated episodes of hypoxia during sleep and sleep fragmentation. It is a highly prevalent though under-recognized clinical problem.There is increasing evidence that inflammation plays important role in development of cardiovascular complications in patients with OSA.
Continuous positive airway pressure (CPAP) is the standard treatment for OSA with significant symptoms.However, it is a costly treatment option and poor compliance is an important limiting factor. CPAP treatment has been shown to improve the daytime somnolence and neurocognitive function in people with OSAS. However, its effect on cardiovascular biomarkers in people with OSAS has not been satisfactorily assessed.
This study aims to assess the effect of CPAP treatment on cardiovascular biomarkers in OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- AutoSet Spirit--Wash--Modified-AutoSet Spirit, Modified-AutoSet Spirit--Wash-AutoSet Spirit
- Keywords
- Obstructive sleep apnea, Cytokine levels, Insulin resistance, Hypertension, Dyslipidemia, Albumin-creatinine ratio, Continuous positive airway pressure (CPAP)
- Medical subject headings
- Sleep Apnea, Obstructive, Insulin Resistance, Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoSet Spirit--Wash--Modified-AutoSet SpiritDevice
Also called AutoSet Spirit(TM), ResMed India Ltd.
3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
Modified-AutoSet Spirit--Wash-AutoSet SpiritDevice
Also called Modified-AutoSet Spirit(TM), ResMed India Ltd.
3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit 3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between Receives: Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit |
| 2 | Other | 3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between Receives: Device: Modified-AutoSet Spirit--Wash-AutoSet Spirit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of CPAP therapy on blood pressure
Measured: 7 months
Effect of CPAP therapy on insulin resistance
Measured: 7months
Effect of CPAP therapy on plasma hs-CRP
Measured: 7months
Effect of CPAP therapy on lipid profile
Measured: 7months
Effect of CPAP therapy on urinary albumin-creatinine ratio
Measured: 7months
Secondary outcomes (5)
Effect of CPAP on anthropometric parameters
Measured: 3 months
Effect of CPAP on visceral fat and other imagings
Measured: 3months
Effect of CPAP on carotid intima medical thickness
Measured: 3months
Effect of CPAP on adipokines and oxidative stress markers
Measured: 3months
Effect of CPAP on inflammatory cytokine levels.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startMar 2012
- Primary completionSep 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S.K.SHARMA, All India Institute of Medical Sciences
- Investigators
- Surendra K Sharma, MD,Ph.D, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138865
- Sponsor's protocol ID
- SKS/CPAP-OSAS/2009
- Acronym
- CPAP
- Status last verified
- Jun 2013
- First submitted
- 2 Jun 2010
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.
- ClinicalTrials.gov ID
- NCT01138865
- Acronym / sponsor ID
- CPAP / SKS/CPAP-OSAS/2009
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Cytokine levels, Insulin resistance, Hypertension, Dyslipidemia, Albumin-creatinine ratio, Continuous positive airway pressure (CPAP)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 8 Jun 2010 (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.
CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of cardiovascular, mortality risks in the same patients.
Detailed description
Obstructive sleep apnea (OSA) is a condition in which there is collapse of the upper airway during sleep, as a result of which there is a decrease or complete cessation of airflow. This leads to repeated episodes of hypoxia during sleep and sleep fragmentation. It is a highly prevalent though under-recognized clinical problem.There is increasing evidence that inflammation plays important role in development of cardiovascular complications in patients with OSA.
Continuous positive airway pressure (CPAP) is the standard treatment for OSA with significant symptoms.However, it is a costly treatment option and poor compliance is an important limiting factor. CPAP treatment has been shown to improve the daytime somnolence and neurocognitive function in people with OSAS. However, its effect on cardiovascular biomarkers in people with OSAS has not been satisfactorily assessed.
This study aims to assess the effect of CPAP treatment on cardiovascular biomarkers in OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: AutoSet Spirit--Wash--Modified-AutoSet SpiritDevice: AutoSet Spirit--Wash--Modified-AutoSet Spirit 3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between |
| 2 | Other | Device: Modified-AutoSet Spirit--Wash-AutoSet Spirit3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The 1st part of the study will include
- males and females, aged 30-65 years,
- with AHI >5 and excessive daytime sleepiness
- naïve to CPAP treatment.
- Subjects from first part of the study who have moderately severe OSAS and have never received treatment for OSA,diabetes mellitus and hypertension
Key exclusion criteria (13 listed)
- Hypothyroidism
- Chronic renal failure
- Chronic liver disease
- Chronic lung disease
- Known systemic inflammatory diseases (lupus , sarcoidosis and other connective tissue disorders),
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 |
|---|---|---|
| AutoSet Spirit--Wash--Modified-AutoSet SpiritAlso: AutoSet Spirit(TM), ResMed India Ltd.3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between | Device | 1 |
| Modified-AutoSet Spirit--Wash-AutoSet SpiritAlso: Modified-AutoSet Spirit(TM), ResMed India Ltd.3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between | Device | 2 |
Primary outcome
Effect of CPAP therapy on blood pressure
Time frame: 7 months
Effect of CPAP therapy on insulin resistance
Time frame: 7months
Effect of CPAP therapy on plasma hs-CRP
Time frame: 7months
Effect of CPAP therapy on lipid profile
Time frame: 7months
Effect of CPAP therapy on urinary albumin-creatinine ratio
Time frame: 7months
5 secondary outcomes
Effect of CPAP on anthropometric parameters
Time frame: 3 months
Effect of CPAP on visceral fat and other imagings
Time frame: 3months
Effect of CPAP on carotid intima medical thickness
Time frame: 3months
Effect of CPAP on adipokines and oxidative stress markers
Time frame: 3months
Effect of CPAP on inflammatory cytokine levels.
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Surendra K Sharma, MD,Ph.D principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AutoSet Spirit--Wash--Modified-AutoSet Spirit and Modified-AutoSet Spirit--Wash-AutoSet Spirit in people with Obstructive Sleep Apnea, run by All India Institute of Medical Sciences at 1 site in India.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Jun 2013. 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 India. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Surendra K Sharma, MD, Ph.D (91-11-26594415, sksharma@aiims.ac.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of CPAP therapy on blood pressure (time frame: 7 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2013.