Patient ComplianceNCT02339597
Therapy Adherence of APAP Therapy Initiation in Sleep-lab Versus at Home
A study testing Automatic Positive Airway Pressure (APAP) initiation in people with Patient Compliance, run by Prof. Dr. Ingo Fietze at 1 site in Germany.
Trial summary
Primary hypothesis: The objective compliance ( # of hours per night of APAP therapy) is higher in patients who get the APAP treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Compliance
- What is being tested?
- Automatic Positive Airway Pressure (APAP) initiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Nov 2015
- 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
- written informed consent from patients after verbally and written informing
- Age between 18 and 80 Years
- obstructive sleep apnea syndrome (OSAS) with an AHI > 15/h and without previous therapy
Who cannot join
- Intolerance to wear the PAP therapy mask
- sleep breathing disorders (SBD) with central apneas > 20% and other sleep disorders
- disabilities who prevents the wear of a therapy mask
- initiated PAP therapy
- pre-treatment of OSAS incl. UPPP (uvulo palato pharyngo plasty)
- modified Mallampati Score T3 and T4
Show all 15Show fewer
- participation on clinical studies 4 weeks before start of the study
- known or acute psychiatric/neurological or psychological disorders, who impairs the compliance to take part of the study.
- chronical or new clinically significant pneumological or cardiovascular disease (exception: effectively therapies of hypertension, cardiac arrhythmia and coronal cardiac disease)
- acute internistic disease
- neuromuscular disease
- condition after Apoplexy
- oncological disease in recent 5 years
- drug/alcohol consumption
- consumption of von psychotropic drugs, hypnotics and other drugs who are able to influence the sleep/wake cycle
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite-Universitaetsmedizin Berlin, Center for Sleep Medicine
Berlin, State of Berlin, 10117
Ingo Fietze, MD, PhD, +4930450513160, ingo.fietze@charite.de
Ingo Fietze, MD, PhD
About this study
Official title: Therapy Adherence in Different Settings of Automatic Positive Airway Pressure (APAP) Therapy Initiation in Patients With Obstructive Sleep Apnea (OSA): Comparison Between in Sleep-lab vs. at Home Environment.
Primary hypothesis:
The objective compliance ( # of hours per night of APAP therapy) is higher in patients who get the APAP treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions.
Secondary hypothesis:
Based on the higher support at the home APAP initiation the following parameters will be better in comparison to the standard supply in laboratory:
Objective measures:
- mask leakage
- pressure
- Apnea-Hypopnea-Index (AHI)
Subjective measures:
- quality of life
- sleepiness
- Conditions
- Patient Compliance
- Being tested
- Automatic Positive Airway Pressure (APAP) initiation
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Positive Airway Pressure (APAP) initiationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| APAP Lab | Experimental | standard Initiation of APAP therapy in sleep laboratory. Receives: Procedure: Automatic Positive Airway Pressure (APAP) initiation |
| APAP Home | Experimental | initiation of APAP therapy in homely environment with additional continuous telemetric support. Receives: Procedure: Automatic Positive Airway Pressure (APAP) initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of usage hours of of positive airway pressure therapy per night
Measured: 6 month
Secondary outcomes (1)
Apnea Hypopnea Index [1 / hour of sleep)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJan 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Ingo Fietze
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Sponsor-investigator, Prof. Dr. Ingo Fietze, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339597
- Sponsor's protocol ID
- EA1/306/13
- Status last verified
- Jan 2015
- First submitted
- 27 Jan 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Adherence in Different Settings of Automatic Positive Airway Pressure (APAP) Therapy Initiation in Patients With Obstructive Sleep Apnea (OSA): Comparison Between in Sleep-lab vs. at Home Environment.
- ClinicalTrials.gov ID
- NCT02339597
- Acronym / sponsor ID
- EA1/306/13
- Conditions
- Patient Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Prof. Dr. Ingo FietzeUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 15 Jan 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.
Primary hypothesis:
The objective compliance ( # of hours per night of APAP therapy) is higher in patients who get the APAP treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions.
Secondary hypothesis:
Based on the higher support at the home APAP initiation the following parameters will be better in comparison to the standard supply in laboratory:
Objective measures:
- mask leakage
- pressure
- Apnea-Hypopnea-Index (AHI)
Subjective measures:
- quality of life
- sleepiness
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APAP Lab | Experimental | Procedure: Automatic Positive Airway Pressure (APAP) initiationstandard Initiation of APAP therapy in sleep laboratory. |
| APAP Home | Experimental | Procedure: Automatic Positive Airway Pressure (APAP) initiationinitiation of APAP therapy in homely environment with additional continuous telemetric support. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent from patients after verbally and written informing
- Age between 18 and 80 Years
- obstructive sleep apnea syndrome (OSAS) with an AHI > 15/h and without previous therapy
Key exclusion criteria (15 listed)
- Intolerance to wear the PAP therapy mask
- sleep breathing disorders (SBD) with central apneas > 20% and other sleep disorders
- disabilities who prevents the wear of a therapy mask
- initiated PAP therapy
- pre-treatment of OSAS incl. UPPP (uvulo palato pharyngo plasty)
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 |
|---|---|---|
| Automatic Positive Airway Pressure (APAP) initiation | Procedure or surgery | APAP Home, APAP Lab |
Primary outcome
Number of usage hours of of positive airway pressure therapy per night
Time frame: 6 month
1 secondary outcome
Apnea Hypopnea Index [1 / hour of sleep)
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Positive Airway Pressure (APAP) initiation in people with Patient Compliance, run by Prof. Dr. Ingo Fietze at 1 site in Germany.
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 15 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 15 Jan 2015. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingo Fietze, MD, PhD (+4930450513160, ingo.fietze@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of usage hours of of positive airway pressure therapy per night (time frame: 6 month). 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 15 Jan 2015.