Sleep Apnea SyndromesNCT03061071
The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea
A study testing NightBalance Sleep Position Trainer (SPT) and Automated Adjusting Positive Airway Pressure (APAP) in people with Sleep Apnea Syndromes, run by NightBalance at 11 sites in United States.
Trial summary
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- NightBalance Sleep Position Trainer (SPT) and Automated Adjusting Positive Airway Pressure (APAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Mar 2017to 12 Jul 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between the ages of 20 and 80.
- Diagnosis of POSA meeting all the following criteria per in-lab control PSG (performed within 3 months of screening):
- Total AHI >15, or AHI >10 and <15 with ESS >10
- Supine AHI at least twice the non-supine AHI
- Non-supine AHI <10 (<5 in mild patients)
- Supine time >40% and <60%
- Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
Who cannot join
- Prior surgery to treat OSA (such as UPPP), or prior or current therapy or treatment for OSA, with the exception of PAP being used for split night PSG only.
- A female of child-bearing potential that is pregnant or intends to become pregnant.
- Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, or at the discretion of the site Principal Investigator (PI).
- Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants.
- Oxygen use.
- The presence of any other sleep disorder (central sleep apnea (CSA >5), periodic limb movement disorder (PLMAI >15), clinical diagnosis of insomnia or narcolepsy).
Show all 12Show fewer
- Excessive alcohol consumption (>21 drinks/week).
- The use of any illegal drug(s).
- Night or rotating shift work.
- Severe claustrophobia.
- Shoulder, neck, or back complaints that restrict sleeping position.
- Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48109
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
St. Luke's Sleep Medicine and Research Center
Chesterfield, Missouri, 63017
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
SleepMed of South Carolina
Columbia, South Carolina, 29201
Med One Sleep
Fayetteville, North Carolina, 28304
Sleep Disorders at Magnolia Park
Gainesville, Florida, 32606
Sleep Med Inc., AZ
Glendale, Arizona, 85306
Kentucky Research Group
Louisville, Kentucky, 40218
Clayton Sleep Institute
Maplewood, Missouri, 63143
Pearl Clinical Research
Paoli, Pennsylvania, 19301
About this study
Official title: A Prospective, Randomized, Crossover Study of the NightBalance Sleep Position Trainer (SPT) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).
Read the detailed description
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of POSA.
The Primary Objective of the study is to demonstrate non-inferiority of treatment with the SPT as compared to APAP.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- NightBalance Sleep Position Trainer (SPT), Automated Adjusting Positive Airway Pressure (APAP)
- Keywords
- Positional Sleep Apnea, Positional Obstructive Sleep Apnea, POSA, OSA, Obstructive Sleep Apnea, Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NightBalance Sleep Position Trainer (SPT)Device
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.
Automated Adjusting Positive Airway Pressure (APAP)Device
Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.
| Study group | Role | What they receive |
|---|---|---|
| Randomized to SPT First: APAP Second | Experimental | Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment. Receives: Device: NightBalance Sleep Position Trainer (SPT); Device: Automated Adjusting Positive Airway Pressure (APAP) |
| Randomized to APAP First: SPT Second | Experimental | Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment. Receives: Device: NightBalance Sleep Position Trainer (SPT); Device: Automated Adjusting Positive Airway Pressure (APAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence (minutes of device use per night)
Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)
Measured: 6 week
Apnea-Hypopnea Index (AHI, events/hr)
Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)
Measured: 6 week
Secondary outcomes (13)
Epworth Sleepiness Scale (ESS)
SPT vs. APAP
Measured: 6 week
Functional Outcomes of Sleep Questionnaire (FOSQ)
SPT vs. APAP
Measured: 6 week
SF-36
SPT vs. APAP
Measured: 6 week
Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)
SPT vs. APAP
Measured: 6 week
Oxygen Desaturation Index (3%)
SPT vs. APAP
Measured: 6 week
Total Sleep Time (minutes)
SPT vs. APAP (measured by in lab polysomnography)
Measured: 6 week
Sleep Onset Latency (minutes)
SPT vs. APAP (measured by in lab polysomnography)
Measured: 6 week
Sleep Efficiency (%)
SPT vs. APAP (measured by in lab polysomnography)
Measured: 6 week
Arousal Index
SPT vs. APAP (measured by in lab polysomnography)
Measured: 6 week
Sleep Stages (%)
SPT vs. APAP (measured by in lab polysomnography)
Measured: 6 week
Sleep Position (%)
SPT vs. APAP (measured by in lab polysomnography)
Measured: 6 week
Mean Disease Alleviation (MDA) (%)
SPT vs. APAP (MDA (%) is calculated by the product of the objective adherence (from SPT and APAP download), adjusted for total sleep time (X-axis), combined with therapeutic efficacy (AHI from the respective treatment night, Y-axis), divided by 100.)
Measured: 6 weeks
Adverse Events
SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
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 Apnea SyndromesStudies 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
- Crossover
- Model description
- 6 week crossover study, randomized to order of treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- NightBalance
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard B Berry, MD, Principal investigator, UF Health Sleep Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061071
- Sponsor's protocol ID
- US-2017-001
- Status last verified
- Aug 2018
- First submitted
- 13 Feb 2017
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Berry RB, Uhles ML, Abaluck BK, Winslow DH, Schweitzer PK, Gaskins RA Jr, Doekel RC Jr, Emsellem HA. NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Jul 15;15(7):947-956. doi: 10.5664/jcsm.7868.
PubMed 31383231
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Crossover Study of the NightBalance Sleep Position Trainer (SPT) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)
- ClinicalTrials.gov ID
- NCT03061071
- Acronym / sponsor ID
- US-2017-001
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Positional Sleep Apnea, Positional Obstructive Sleep Apnea, POSA, OSA, Obstructive Sleep Apnea, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- NightBalanceIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 23 Feb 2017 (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.
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).
Detailed description
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of POSA.
The Primary Objective of the study is to demonstrate non-inferiority of treatment with the SPT as compared to APAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 6 week crossover study, randomized to order of treatment
| Arm | Type | Receives |
|---|---|---|
| Randomized to SPT First: APAP Second | Experimental | Device: NightBalance Sleep Position Trainer (SPT), Device: Automated Adjusting Positive Airway Pressure (APAP)Randomized to order of treatment (SPT first or APAP first) for a total of 6 weeks home use with each treatment. |
| Randomized to APAP First: SPT Second | Experimental | Device: NightBalance Sleep Position Trainer (SPT), Device: Automated Adjusting Positive Airway Pressure (APAP)Randomized to order of treatment (APAP first or SPT first) for a total of 6 weeks home use with each treatment. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is between the ages of 20 and 80.
- Diagnosis of POSA meeting all the following criteria per in-lab control PSG (performed within 3 months of screening):
- Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
Key exclusion criteria (12 listed)
- Prior surgery to treat OSA (such as UPPP), or prior or current therapy or treatment for OSA, with the exception of PAP being used for split night PSG only.
- A female of child-bearing potential that is pregnant or intends to become pregnant.
- Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, or at the discretion of the site Principal Investigator (PI).
- Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants.
- Oxygen use.
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 |
|---|---|---|
| NightBalance Sleep Position Trainer (SPT)Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG. | Device | Randomized to APAP First: SPT Second, Randomized to SPT First: APAP Second |
| Automated Adjusting Positive Airway Pressure (APAP)Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG. | Device | Randomized to APAP First: SPT Second, Randomized to SPT First: APAP Second |
Primary outcome
Adherence (minutes of device use per night)
Time frame: 6 week
Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)
Apnea-Hypopnea Index (AHI, events/hr)
Time frame: 6 week
Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)
13 secondary outcomes
Epworth Sleepiness Scale (ESS)
Time frame: 6 week
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 6 week
SF-36
Time frame: 6 week
Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)
Time frame: 6 week
Oxygen Desaturation Index (3%)
Time frame: 6 week
Total Sleep Time (minutes)
Time frame: 6 week
Sleep Onset Latency (minutes)
Time frame: 6 week
Sleep Efficiency (%)
Time frame: 6 week
Arousal Index
Time frame: 6 week
Sleep Stages (%)
Time frame: 6 week
Sleep Position (%)
Time frame: 6 week
Mean Disease Alleviation (MDA) (%)
Time frame: 6 weeks
Adverse Events
Time frame: 6 weeks
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 21 Aug 2018.
- Derived from this study: PubMed 31383231Berry RB, Uhles ML, Abaluck BK, Winslow DH, Schweitzer PK, Gaskins RA Jr, Doekel RC Jr, Emsellem HA. NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Jul 15;15(7):947-956. doi: 10.5664/jcsm.7868.
- Individual participant dataSharing planned: No
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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.
Richard B Berry, MD principal investigator
UF Health Sleep Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NightBalance Sleep Position Trainer (SPT) and Automated Adjusting Positive Airway Pressure (APAP) in people with Sleep Apnea Syndromes, run by NightBalance at 11 sites 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 7 inclusion and 12 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 21 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 11 sites 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?
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?
Adherence (minutes of device use per night) (time frame: 6 week). The study lists 2 primary outcomes in all. 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 NCT03061071, 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 21 Aug 2018.