Obstructive Sleep ApneaNCT01637831
CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea
A study testing Continuous Positive Airway Pressure (CPAP) in people with Obstructive Sleep Apnea and Idiopathic Pulmonary Fibrosis, run by University of Crete at 1 site in Greece.
Trial summary
The recent literature shows an increased incidence of obstructive sleep apnea (OSA) in patients with idiopathic pulmonary fibrosis (IPF). On the other hand there are no published studies related to CPAP treatment in this patient group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2010to Sep 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with apnoea-hypopnoea index >15/h
- Newly diagnosed IPF
Who cannot join
- Congestive heart failure
- Chronic renal failure
Trial locations and contacts
1 site in 1 country.
Greece1 site
Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete
Heraklion, Crete, 71110
About this study
Official title: CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Obstructive Sleep Apnea. Does It Offer a Better Quality of Life and Sleep?
The recent literature shows an increased incidence of obstructive sleep apnea (OSA) in patients with idiopathic pulmonary fibrosis (IPF). On the other hand there are no published studies related to CPAP treatment in this patient group. The investigators aim was to assess the effect of CPAP on sleep and overall life quality parameters in IPF patients with OSA and to recognize and overcome possible difficulties in CPAP initiation and acceptance by these patients.
Read the detailed description
Recently published studies report a high incidence of obstructive sleep apnea (OSA) in patients with IPF. Underlying, and usually under-diagnosed OSA in these patients may be a reason for impaired sleep quality and may consequently have a negative influence on their daily activities and overall quality of life. In addition, underlying OSA may have a negative influence on the already impaired IPF-related morbidity and mortality. The absence of any effective treatment for IPF so far indicates that the recognition and treatment of generally under-diagnosed OSA in IPF patients should be a primary goal. Therefore, our primary aim in this study was to assess the results of effective CPAP therapy in terms of sleep quality and overall quality of life in IPF patients with moderate to severe OSA. The investigators used generally accepted instruments to assess quality of sleep and overall life. In addition, the investigators tried to determine and overcome the reasons for poor CPAP compliance in these patients
- Being tested
- Continuous Positive Airway Pressure (CPAP)
- Keywords
- Obstructive Sleep Apnea, Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Sleep Apnea, Obstructive, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Procedure or surgery
Also called positive pressure ventilation
Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment completion of questionnaires assessing sleep and quality of life 1, 3 and 6 months after the start of effective CPAP treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients with OSA and IPF | Experimental | Participants with Obstructive Sleep Apnea (OSA)and Idiopathic Pulmonary Fibrosis (IPF).This arm will complete pre-treatment questionnaires assessing sleep and quality of life, undergo six months of Continuous Positive Airway Pressure (CPAP) to treat OSA, and complete post-treatment the same questionnaires 1, 3 and 6 months later. Receives: Procedure: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overal quality of life parameters in IPF patients with OSA after the start of effective CPAP treatment
Measured: Day 1, Month 1, 3 and Month 6 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startMar 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charalampos Mermigkis, University of Crete
- Investigators
- Sophia E Schiza, MD, PhD, Study chair, University of CreteCharalampos Mermigkis, MD, Study director, Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, GreeceIzolde Bouloukaki, MD, PhD, Principal investigator, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637831
- Sponsor's protocol ID
- CPAPIPF-02
- Status last verified
- Jul 2012
- First submitted
- 4 Jul 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Papadogiannis G, Bouloukaki I, Mermigkis C, Michelakis S, Ermidou C, Mauroudi E, Moniaki V, Tzanakis N, Antoniou KM, Schiza SE. Patients with idiopathic pulmonary fibrosis with and without obstructive sleep apnea: differences in clinical characteristics, clinical outcomes, and the effect of PAP treatment. J Clin Sleep Med. 2021 Mar 1;17(3):533-544. doi: 10.5664/jcsm.8932.
PubMed 33108270Mermigkis C, Bouloukaki I, Antoniou KM, Mermigkis D, Psathakis K, Giannarakis I, Varouchakis G, Siafakas N, Schiza SE. CPAP therapy in patients with idiopathic pulmonary fibrosis and obstructive sleep apnea: does it offer a better quality of life and sleep? Sleep Breath. 2013 Dec;17(4):1137-43. doi: 10.1007/s11325-013-0813-8. Epub 2013 Feb 6.
PubMed 23386371
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Obstructive Sleep Apnea. Does It Offer a Better Quality of Life and Sleep?
- ClinicalTrials.gov ID
- NCT01637831
- Acronym / sponsor ID
- CPAPIPF-02
- Keywords
- Obstructive Sleep Apnea, Idiopathic Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Jul 2012 (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 recent literature shows an increased incidence of obstructive sleep apnea (OSA) in patients with idiopathic pulmonary fibrosis (IPF). On the other hand there are no published studies related to CPAP treatment in this patient group. The investigators aim was to assess the effect of CPAP on sleep and overall life quality parameters in IPF patients with OSA and to recognize and overcome possible difficulties in CPAP initiation and acceptance by these patients.
Detailed description
Recently published studies report a high incidence of obstructive sleep apnea (OSA) in patients with IPF. Underlying, and usually under-diagnosed OSA in these patients may be a reason for impaired sleep quality and may consequently have a negative influence on their daily activities and overall quality of life. In addition, underlying OSA may have a negative influence on the already impaired IPF-related morbidity and mortality. The absence of any effective treatment for IPF so far indicates that the recognition and treatment of generally under-diagnosed OSA in IPF patients should be a primary goal. Therefore, our primary aim in this study was to assess the results of effective CPAP therapy in terms of sleep quality and overall quality of life in IPF patients with moderate to severe OSA. The investigators used generally accepted instruments to assess quality of sleep and overall life. In addition, the investigators tried to determine and overcome the reasons for poor CPAP compliance in these patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with OSA and IPF | Experimental | Procedure: Continuous Positive Airway Pressure (CPAP)Participants with Obstructive Sleep Apnea (OSA)and Idiopathic Pulmonary Fibrosis (IPF).This arm will complete pre-treatment questionnaires assessing sleep and quality of life, undergo six months of Continuous Positive Airway Pressure (CPAP) to treat OSA, and complete post-treatment the same questionnaires 1, 3 and 6 months later. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with apnoea-hypopnoea index >15/h
- Newly diagnosed IPF
Key exclusion criteria (2 listed)
- Congestive heart failure
- Chronic renal failure
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 Airway Pressure (CPAP)Also: positive pressure ventilationContinuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment completion of questionnaires assessing sleep and quality of life 1, 3 and 6 months after the start of effective CPAP treatment. | Procedure or surgery | Patients with OSA and IPF |
Primary outcome
Change in overal quality of life parameters in IPF patients with OSA after the start of effective CPAP treatment
Time frame: Day 1, Month 1, 3 and Month 6 post treatment
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 11 Jul 2012.
- Derived from this study: PubMed 33108270Papadogiannis G, Bouloukaki I, Mermigkis C, Michelakis S, Ermidou C, Mauroudi E, Moniaki V, Tzanakis N, Antoniou KM, Schiza SE. Patients with idiopathic pulmonary fibrosis with and without obstructive sleep apnea: differences in clinical characteristics, clinical outcomes, and the effect of PAP treatment. J Clin Sleep Med. 2021 Mar 1;17(3):533-544. doi: 10.5664/jcsm.8932.
- Derived from this study: PubMed 23386371Mermigkis C, Bouloukaki I, Antoniou KM, Mermigkis D, Psathakis K, Giannarakis I, Varouchakis G, Siafakas N, Schiza SE. CPAP therapy in patients with idiopathic pulmonary fibrosis and obstructive sleep apnea: does it offer a better quality of life and sleep? Sleep Breath. 2013 Dec;17(4):1137-43. doi: 10.1007/s11325-013-0813-8. Epub 2013 Feb 6.
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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.
Sophia E Schiza, MD, PhD study chair
University of Crete
Charalampos Mermigkis, MD study director
Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
Izolde Bouloukaki, MD, PhD principal investigator
University of Crete
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 Airway Pressure (CPAP) in people with Obstructive Sleep Apnea and Idiopathic Pulmonary Fibrosis, run by University of Crete at 1 site in Greece.
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 2 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 11 Jul 2012. 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 Greece. 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 in overal quality of life parameters in IPF patients with OSA after the start of effective CPAP treatment (time frame: Day 1, Month 1, 3 and Month 6 post treatment). 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 NCT01637831, which also lists 2 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 11 Jul 2012.