Obstructive Sleep ApneaNCT00988351
Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea
A study testing Continuous positive airway pressure and Auto-adjusting positive airway pressure treatment in people with Obstructive Sleep Apnea, run by North Florida Foundation for Research and Education at 1 site in United States.
Trial summary
The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airway pressure and Auto-adjusting positive airway pressure treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OSA, Apnea-hypopnea index > 5/hour
Who cannot join
- Prior CPAP
- Uncontrolled Depression
- Moderate to Severe chronic obstructive pulmonary disease (COPD)
- Hypoventilation
- Average estimated nightly total sleep time < 4 hours
- Shift work
Show all 13Show fewer
- Unstable depression
- Upper airway surgery
- Uncontrolled Restless legs syndrome (RLS), narcolepsy
- Use of supplemental oxygen
- Severe congestive heart failure
- Use of nightly potent narcotics
- Severe obesity (BMI > 40)
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
About this study
Official title: Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA
The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended sleep study) followed by CPAP treatment. The other pathway involves treatment with auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two study arms.
Read the detailed description
RESEARCH PLAN: All patients being evaluated for possible OSA are required to attend a Sleep Education and Evaluation Class before having a sleep study. At this class they receive information on sleep apnea, PAP treatment, and the types of sleep studies. They also complete a sleep questionnaire to identify co-existing sleep disorders and important co-morbid medical conditions. Screening of the sleep questionnaire and the patient's medical record is part of routine care to identify patients needing a diagnostic PSG and/or an attended titration. At the end of the class, participation in the current study will be offered the patients. Those signifying interest in being part of the research study and meeting inclusion and exclusion criteria will be contacted to participate in the study. Once they sign an informed consent they will be randomized to one of the two clinical pathways.
METHODS: Study visits:
Before informed consent (routine clinical care)
- Sleep Education and Evaluation Class (education about OSA, sleep studies, and OSA treatment). Patients complete screening sleep and medical history questionnaires.
- Determination of patient interest in participating in the current study and review of inclusion/exclusion criteria
After informed consent
- PM study
- Randomization if the Portable monitoring (PM) study is diagnostic of OSA. If not, the patient will be offered a diagnostic PSG. If this is positive, they will have APAP treatment. If both the PM and PSG are negative for OSA the patient exits the study but will be followed in sleep clinic.
- PSG for CPAP titration (PSG arm only).
- CPAP/APAP setup - patient fills out Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ). The same Research coordinator/Respiratory therapist will setup the units, fit masks, and instruct the patients on the use of their device. Patients being treated with CPAP or APAP will be in separate classes.
- Telephone contact within 7 days of setup with early intervention for PAP problems if needed.
- Clinic visit 6 weeks after starting treatment: download objective adherence, ESS, FOSQ, and PAP satisfaction questionnaire.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous positive airway pressure, Auto-adjusting positive airway pressure treatment
- Keywords
- sleep apnea, positive airway pressure, portable monitoring, auto positive airway pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Also called CPAP
continuous positive airway pressure determined by polysomnography titration
Auto-adjusting positive airway pressure treatmentDevice
Also called AutoCPAP, APAP
Pressure range 4-18 centimeters of water (cm H2O)
| Study group | Role | What they receive |
|---|---|---|
| PSG CPAP titration then CPAP treatment | Active comparator | Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment Receives: Device: Continuous positive airway pressure |
| Auto-Adjusting Positive Airway Pressure | Active comparator | Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. Receives: Device: Auto-adjusting positive airway pressure treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Airway Pressure Adherence (Nightly Use of Treatment)
average nightly hours of using positive airway pressure (including 0 for nights not used)
Measured: 6 weeks after starting treatment
Secondary outcomes (4)
Change in Epworth Sleepiness Scale
Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.
Measured: 6 weeks after starting treatment
Change in Functional Outcomes of Sleep Questionnaire
The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.
Measured: 6 weeks at clinic
Residual Apnea-hypopnea Index
The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI < 10 is considered adequate treatment and <5/hour ideal treatment.
Measured: over first 6 weeks of treatment
Treatment Pressure (Level of CPAP or 90th Percentile APAP)
The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.
Measured: 6 weeks clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Florida Foundation for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Berry, North Florida Foundation for Research and Education
- Investigators
- Richard B Berry, MD, Principal investigator, University of Florida/Malcom Randall VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988351
- Sponsor's protocol ID
- UFIRB#384-09
- Status last verified
- Oct 2014
- First submitted
- 1 Oct 2009
- Last updated
- 3 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA
- ClinicalTrials.gov ID
- NCT00988351
- Acronym / sponsor ID
- UFIRB#384-09
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep apnea, positive airway pressure, portable monitoring, auto positive airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- North Florida Foundation for Research and EducationUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Posted 3 Nov 2014
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 randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended sleep study) followed by CPAP treatment. The other pathway involves treatment with auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two study arms.
Detailed description
RESEARCH PLAN: All patients being evaluated for possible OSA are required to attend a Sleep Education and Evaluation Class before having a sleep study. At this class they receive information on sleep apnea, PAP treatment, and the types of sleep studies. They also complete a sleep questionnaire to identify co-existing sleep disorders and important co-morbid medical conditions. Screening of the sleep questionnaire and the patient's medical record is part of routine care to identify patients needing a diagnostic PSG and/or an attended titration. At the end of the class, participation in the current study will be offered the patients. Those signifying interest in being part of the research study and meeting inclusion and exclusion criteria will be contacted to participate in the study. Once they sign an informed consent they will be randomized to one of the two clinical pathways.
METHODS: Study visits:
Before informed consent (routine clinical care)
- Sleep Education and Evaluation Class (education about OSA, sleep studies, and OSA treatment). Patients complete screening sleep and medical history questionnaires.
- Determination of patient interest in participating in the current study and review of inclusion/exclusion criteria
After informed consent
- PM study
- Randomization if the Portable monitoring (PM) study is diagnostic of OSA. If not, the patient will be offered a diagnostic PSG. If this is positive, they will have APAP treatment. If both the PM and PSG are negative for OSA the patient exits the study but will be followed in sleep clinic.
- PSG for CPAP titration (PSG arm only).
- CPAP/APAP setup - patient fills out Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ). The same Research coordinator/Respiratory therapist will setup the units, fit masks, and instruct the patients on the use of their device. Patients being treated with CPAP or APAP will be in separate classes.
- Telephone contact within 7 days of setup with early intervention for PAP problems if needed.
- Clinic visit 6 weeks after starting treatment: download objective adherence, ESS, FOSQ, and PAP satisfaction questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSG CPAP titration then CPAP treatment | Active comparator | Device: Continuous positive airway pressurePatients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment |
| Auto-Adjusting Positive Airway Pressure | Active comparator | Device: Auto-adjusting positive airway pressure treatmentFollowing diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- OSA, Apnea-hypopnea index > 5/hour
Key exclusion criteria (13 listed)
- Prior CPAP
- Uncontrolled Depression
- Moderate to Severe chronic obstructive pulmonary disease (COPD)
- Hypoventilation
- Average estimated nightly total sleep time < 4 hours
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 pressureAlso: CPAPcontinuous positive airway pressure determined by polysomnography titration | Device | PSG CPAP titration then CPAP treatment |
| Auto-adjusting positive airway pressure treatmentAlso: AutoCPAP, APAPPressure range 4-18 centimeters of water (cm H2O) | Device | Auto-Adjusting Positive Airway Pressure |
Primary outcome
Positive Airway Pressure Adherence (Nightly Use of Treatment)
Time frame: 6 weeks after starting treatment
average nightly hours of using positive airway pressure (including 0 for nights not used)
4 secondary outcomes
Change in Epworth Sleepiness Scale
Time frame: 6 weeks after starting treatment
Change in Functional Outcomes of Sleep Questionnaire
Time frame: 6 weeks at clinic
Residual Apnea-hypopnea Index
Time frame: over first 6 weeks of treatment
Treatment Pressure (Level of CPAP or 90th Percentile APAP)
Time frame: 6 weeks clinic
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obstructive Sleep Apnea
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.
Richard B Berry, MD principal investigator
University of Florida/Malcom Randall VAMC
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 and Auto-adjusting positive airway pressure treatment in people with Obstructive Sleep Apnea, run by North Florida Foundation for Research and Education at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 3 Nov 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Positive Airway Pressure Adherence (Nightly Use of Treatment) (time frame: 6 weeks after starting treatment). 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 3 Nov 2014.