Sleep ApneaNCT02016339
Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance
A study testing Intensive care in people with Sleep Apnea, run by University of Crete.
Trial summary
The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Intensive care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,836 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Oct 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria,
- with moderate to severe sleep apnea,
- no history of previously CPAP therapy and
- with an above-elementary school education.
Who cannot join
- refusal to participate,
- refusal to CPAP therapy,
- previous CPAP treatment,
- central sleep apnoea syndrome,
- Cheyne-stokes breathing pattern,
- obesity hypoventilation syndrome,
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- restrictive ventilator syndromes,
- congestive heart failure,
- history of life-threatening arrhythmias,
- cardiomyopathy,
- long term oxygen therapy,
- family or personal history of mental illness,
- with drug or alcohol abuse,
- severe cognitive impairment,
- concurrent oncologic diseases and
- history of narcolepsy.
About this study
Official title: Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience
The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
Read the detailed description
There is limited data concerning long-term randomized clinical trials proving the long-term efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
- Conditions
- Sleep Apnea
- Being tested
- Standard care, Intensive care
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careBehavioural
24-h consultation telephone line to the sleep nurses to answer questions regarding CPAP usage. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic by the nurse. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy.
Intensive careBehavioural
Standard group care plus: Involvement of the patient's partner or family necessary. Extra education on sleep apnea and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses after CPAP titration study. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | 24 hour consultation telephone line to the sleep nurses will be open for the patients. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy Receives: Behavioral: Standard care |
| Intensive care | Active comparator | Standard group care plus:
Involvement of the patient's partner or family. Extra education on sleep apnea syndrome and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence. Receives: Behavioral: Intensive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of intensive intervention on CPAP adherence
Measured: 24 months
Secondary outcomes (3)
Effect of intensive intervention on sleepiness.
Measured: 24 months
Effect of intensive intervention on mood.
Measured: 24 months
Effect of intensive intervention on quality of life
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJun 2007
- Primary completionJun 2013
- Study completionOct 2013
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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,836 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izolde Bouloukaki, University of Crete
- Investigators
- Sophia E Schiza, MD, PhD, Study chair, University of CreteCharalampos Mermigkis, MD, PhD, 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
- NCT02016339
- Sponsor's protocol ID
- CPAPCOMPL-01
- Status last verified
- Dec 2013
- First submitted
- 27 Nov 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bouloukaki I, Giannadaki K, Mermigkis C, Tzanakis N, Mauroudi E, Moniaki V, Michelakis S, Siafakas NM, Schiza SE. Intensive versus standard follow-up to improve continuous positive airway pressure compliance. Eur Respir J. 2014 Nov;44(5):1262-74. doi: 10.1183/09031936.00021314. Epub 2014 Jul 3.
PubMed 24993911
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience
- ClinicalTrials.gov ID
- NCT02016339
- Acronym / sponsor ID
- CPAPCOMPL-01
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,836 participants (actual)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Dec 2013 (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 was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
Detailed description
There is limited data concerning long-term randomized clinical trials proving the long-term efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard care24 hour consultation telephone line to the sleep nurses will be open for the patients. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy |
| Intensive care | Active comparator | Behavioral: Intensive careStandard group care plus: Involvement of the patient's partner or family. Extra education on sleep apnea syndrome and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria,
- with moderate to severe sleep apnea,
- no history of previously CPAP therapy and
- with an above-elementary school education.
Key exclusion criteria (16 listed)
- refusal to participate,
- refusal to CPAP therapy,
- previous CPAP treatment,
- central sleep apnoea syndrome,
- Cheyne-stokes breathing pattern,
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 |
|---|---|---|
| Standard care24-h consultation telephone line to the sleep nurses to answer questions regarding CPAP usage. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic by the nurse. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy. | Behavioural | Standard Care |
| Intensive careStandard group care plus: Involvement of the patient's partner or family necessary. Extra education on sleep apnea and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses after CPAP titration study. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence | Behavioural | Intensive care |
Primary outcome
Effect of intensive intervention on CPAP adherence
Time frame: 24 months
3 secondary outcomes
Effect of intensive intervention on sleepiness.
Time frame: 24 months
Effect of intensive intervention on mood.
Time frame: 24 months
Effect of intensive intervention on quality of life
Time frame: 24 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 23 Dec 2013.
- Derived from this study: PubMed 24993911Bouloukaki I, Giannadaki K, Mermigkis C, Tzanakis N, Mauroudi E, Moniaki V, Michelakis S, Siafakas NM, Schiza SE. Intensive versus standard follow-up to improve continuous positive airway pressure compliance. Eur Respir J. 2014 Nov;44(5):1262-74. doi: 10.1183/09031936.00021314. Epub 2014 Jul 3.
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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, PhD study director
Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
Izolde Bouloukaki, MD, PhD principal investigator
University of Crete
Questions about this trial
What is this clinical trial studying?
A study testing Intensive care in people with Sleep Apnea, run by University of Crete.
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 4 inclusion and 16 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 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Effect of intensive intervention on CPAP adherence (time frame: 24 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 NCT02016339, 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 23 Dec 2013.