OSANCT03644121
Adherence to CPAP in Patients With OSA. Ten Year Follow up
An observational study of OSA and Adherence, Patient, run by Maugeri Foundation at 1 site in Italy.
Trial summary
The management of OSA is aimed to improve symptoms and mitigate reduce other health consequences. Continuous Positive Airway Pressure (CPAP) is the recognized treatment for OSA, able to reverse the pathophysiology of OSA and improving sleep continuity, resulting in improvements in daytime sleepiness and quality of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- OSA, Adherence, Patient, CPAP
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2006to 6 Jul 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diagnosis of OSA. According to the International Classification of Sleep Disorders, OSA was defined as the presence of 5 or more obstructive respiratory events (apnea, hypopnea or respiratory effort-related arousal) per hour of sleep plus daytime or nighttime symptoms of OSA, alternatively as the presence of 15 or more obstructive respiratory events per hour of sleep
Who may be able to join
- diagnosis of OSA
- admitted for adaptation to CPAP
Who cannot join
- other sleep related diseases
- concomitant lung or thoracic diseases (including chronic respiratory failure requiring long term oxygen therapy)
- major comorbidities (e.g. psychiatric conditions, cancer, end-stage renal failure)
- familiar conditions preventing long-term home CPAP
- patients already treated with CPAP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence to Continuous Positive Airway Pressure in Patients With Obstructive Sleep Apnoea Syndrome. Ten Year Follow up
The management of OSA is aimed to improve symptoms and mitigate reduce other health consequences. Continuous Positive Airway Pressure (CPAP) is the recognized treatment for OSA, able to reverse the pathophysiology of OSA and improving sleep continuity, resulting in improvements in daytime sleepiness and quality of life (QoL). However, low adherence to this treatment reduces the potential to achieve these benefits. The aim of this real life retrospective observational study was to assess the adherence to CPAP at 12 month and 10 years. The investigators evaluated also predicitve factors of adherence.
Read the detailed description
Methods The protocol was approved (2215 CE, June, 19, 2018) by the Ethical Committee of the Istituti Clinici Scientifici (ICS) Maugeri, Pavia, Italy. All patients at admission to the Scientific Institute of Tradate gave the informed consent to the scientific use of their data.
Study Participants This study was conducted on a database of patients' discharge records, available between August, 2006 and December, 2009.
Adaptation to CPAP: titration of CPAP was performed either by full-night manual titration according to the AASM Guidelines or by automatic titration with Auto-Set systems. Further 4 day-time hours of adaptation were performed along two days. Patients underwent also four face to face sessions with the respiratory therapist, for feed-back of adaptation, optimal comprehension of procedure of CPAP management. The presence of a caregiver (if any) was strongly suggested.
Statistical Analysis An ad hoc electronic form was created to collect all study variables. Qualitative variables were described with absolute and relative (percentages) frequencies, whereas quantitative variables were summarized with means (standard deviations) or medians (interquartile ranges) based on their normal distribution, respectively.
In-between comparison for qualitative and quantitative variables was performed with the chi-squared or Fisher exact test when appropriate, and Student t or Mann-Whitney test in case of parametric or non-parametric distribution, respectively. Comparison of the temporal variation of continuous variables for the same group was assessed with Anova or Friedman's test, depending on their normal distribution.
Uni- and multi-variable logistic regression analysis was performed to assess which covariates could be associated with the adherence to CPAP.
A two-tailed p-value <0.05 was considered significant. All statistical analyses were carried out using the statistical software STATA version 15 (StatsCorp, Texas).
- Conditions
- OSA, Adherence, Patient, CPAP
- Medical subject headings
- Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP use
number of Night-time hours of use (device counter)
Measured: Every 12 month for 10 years.Scale from 0 to 8 hours/night. Values >4,5 hours/night are considered to be a better outcome
Secondary outcomes (2)
Body weight
Kg
Measured: once a year for 10 years
Reported patients' day-time sleepiness
Epworth Sleepness Scale (ESS).The questionnaire asks the subject to rate his/her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought
Measured: once a year for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Aug 2006
- Primary completion1 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maugeri Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, elisabetta zampogna, Maugeri Foundation
- Investigators
- Antonio Spanevello, Prof MD, Study director, Maugeri Foundation, Insubria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644121
- Sponsor's protocol ID
- 2215CE
- Status last verified
- Aug 2018
- First submitted
- 10 Jul 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Continuous Positive Airway Pressure in Patients With Obstructive Sleep Apnoea Syndrome. Ten Year Follow up
- ClinicalTrials.gov ID
- NCT03644121
- Acronym / sponsor ID
- 2215CE
- Conditions
- OSA, Adherence, Patient, CPAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Maugeri FoundationUniversity, hospital or other
- Study start
- 1 Aug 2006 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 23 Aug 2018 (actual)
- 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 management of OSA is aimed to improve symptoms and mitigate reduce other health consequences. Continuous Positive Airway Pressure (CPAP) is the recognized treatment for OSA, able to reverse the pathophysiology of OSA and improving sleep continuity, resulting in improvements in daytime sleepiness and quality of life (QoL). However, low adherence to this treatment reduces the potential to achieve these benefits. The aim of this real life retrospective observational study was to assess the adherence to CPAP at 12 month and 10 years. The investigators evaluated also predicitve factors of adherence.
Detailed description
Methods The protocol was approved (2215 CE, June, 19, 2018) by the Ethical Committee of the Istituti Clinici Scientifici (ICS) Maugeri, Pavia, Italy. All patients at admission to the Scientific Institute of Tradate gave the informed consent to the scientific use of their data.
Study Participants This study was conducted on a database of patients' discharge records, available between August, 2006 and December, 2009.
Adaptation to CPAP: titration of CPAP was performed either by full-night manual titration according to the AASM Guidelines or by automatic titration with Auto-Set systems. Further 4 day-time hours of adaptation were performed along two days. Patients underwent also four face to face sessions with the respiratory therapist, for feed-back of adaptation, optimal comprehension of procedure of CPAP management. The presence of a caregiver (if any) was strongly suggested.
Statistical Analysis An ad hoc electronic form was created to collect all study variables. Qualitative variables were described with absolute and relative (percentages) frequencies, whereas quantitative variables were summarized with means (standard deviations) or medians (interquartile ranges) based on their normal distribution, respectively.
In-between comparison for qualitative and quantitative variables was performed with the chi-squared or Fisher exact test when appropriate, and Student t or Mann-Whitney test in case of parametric or non-parametric distribution, respectively. Comparison of the temporal variation of continuous variables for the same group was assessed with Anova or Friedman's test, depending on their normal distribution.
Uni- and multi-variable logistic regression analysis was performed to assess which covariates could be associated with the adherence to CPAP.
A two-tailed p-value <0.05 was considered significant. All statistical analyses were carried out using the statistical software STATA version 15 (StatsCorp, Texas).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diagnosis of OSA. According to the International Classification of Sleep Disorders, OSA was defined as the presence of 5 or more obstructive respiratory events (apnea, hypopnea or respiratory effort-related arousal) per hour of sleep plus daytime or nighttime symptoms of OSA, alternatively as the presence of 15 or more obstructive respiratory events per hour of sleep
Key inclusion criteria (2 listed)
- diagnosis of OSA
- admitted for adaptation to CPAP
Key exclusion criteria (5 listed)
- other sleep related diseases
- concomitant lung or thoracic diseases (including chronic respiratory failure requiring long term oxygen therapy)
- major comorbidities (e.g. psychiatric conditions, cancer, end-stage renal failure)
- familiar conditions preventing long-term home CPAP
- patients already treated with CPAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CPAP use
Time frame: Every 12 month for 10 years.Scale from 0 to 8 hours/night. Values >4,5 hours/night are considered to be a better outcome
number of Night-time hours of use (device counter)
2 secondary outcomes
Body weight
Time frame: once a year for 10 years
Reported patients' day-time sleepiness
Time frame: once a year for 10 years
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 23 Aug 2018.
- Individual participant dataSharing planned: Yes. Publication
Related trials for OSA
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Antonio Spanevello, Prof MD study director
Maugeri Foundation, Insubria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA and Adherence, Patient, run by Maugeri Foundation at 1 site in Italy.
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 5 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 23 Aug 2018. 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 Italy. 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?
CPAP use (time frame: Every 12 month for 10 years.Scale from 0 to 8 hours/night. Values >4,5 hours/night are considered to be a better outcome). 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 23 Aug 2018.