Obstructive Sleep ApneaNCT02032706
Validation of Safety and Efficacy for Night Shift Therapy
A study testing Deliver therapy when the supine position is detected in people with Obstructive Sleep Apnea, run by Advanced Brain Monitoring, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Deliver therapy when the supine position is detected
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Neck, back or should pain which would impact ability to sleep laterally each night
- Body mass index > 35
- suffering from neurological disorders which result in ticks or tremors
- diagnosed with congestive heart failure or chronic obstructive pulmonary disease
- suffered from a stroke within the previous 12 months
- taking or planning to take narcotic medications
Show all 9Show fewer
- unfamiliar with use of internet browsers
- travel (i.e., foreign or cruise ship) which would limit internet or mail access
- planned medical procedures (e.g., surgery) which would limit device use during the scheduled 30-day study period or introduce the need for narcotic pain medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Complete Sleep Solutions
Murrieta, California, 92563
About this study
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
Read the detailed description
The protocol is designed to first evaluate the accuracy of supine vs. non-supine detection in 15 subjects (hereafter referred to as study 1). In study 2, patients who had completed a baseline polysomnography (PSG) with a minimum of four hours of sleep time were to wear the Night Shift for two nights without feedback to confirm their willingness to continue with the study, followed by 28 nights of vibro-tactile position therapy. A follow-up PSG was to be conducted as soon as possible to the completion of the 28-nights of treatment. During enrollment subjects were to complete pre-treatment questionnaires designed to measure daytime sleepiness, insomnia severity, depression, anxiety, and quality of life. The same instruments were completed post-treatment on the morning after the 28th night of treatment. Subjects completed daily logs to confirm device utilization and identify potential non-device related factors that could influence study completion.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Deliver therapy when the supine position is detected
- Keywords
- obstructive sleep apnea, position therapy, snoring, positional
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deliver therapy when the supine position is detectedDevice
Also called Night Shift
Application of vibrotactile feedback to the neck when the supine position is detected
| Study group | Role | What they receive |
|---|---|---|
| Positional feedback | Experimental | Deliver therapy when the supine position is detected Receives: Device: Deliver therapy when the supine position is detected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events
Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.
Measured: Four weeks
Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy
Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.
Measured: 30-days
Secondary outcomes (8)
Confirmation That Night Shift Accurately Detects Supine Position
Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard).
Measured: baseline and 4-weeks later at follow up
Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant
Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant.
Measured: four weeks
Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback
Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use
Measured: four weeks
Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA
The percentage of compliant participants who show an improved Epworth Sleepiness Score of >= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy.
Measured: baseline and followup
Evaluate Impact of Positional Therapy on Quality of Life Scores
Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate >2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired.
Measured: four weeks
Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake
Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy.
Measured: baseline and follow-up
Assess the Accuracy of Night Shift's Measurement of Total Sleep Time
Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device.
Measured: one night
Assess the Accuracy of Night Shift Measurement of Sleep Efficiency
Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Brain Monitoring, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel J Levendowski, MBA, Principal investigator, Advanced Brain Monitoring, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032706
- Sponsor's protocol ID
- 201301
- Status last verified
- Jun 2014
- First submitted
- 8 Jan 2014
- Last updated
- 1 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Levendowski DJ, Seagraves S, Popovic D, Westbrook PR. Assessment of a neck-based treatment and monitoring device for positional obstructive sleep apnea. J Clin Sleep Med. 2014 Aug 15;10(8):863-71. doi: 10.5664/jcsm.3956.
PubMed 25126032Levendowski DJ, Veljkovic B, Seagraves S, Westbrook PR. Capability of a neck worn device to measure sleep/wake, airway position, and differentiate benign snoring from obstructive sleep apnea. J Clin Monit Comput. 2015 Feb;29(1):53-64. doi: 10.1007/s10877-014-9569-3. Epub 2014 Mar 6.
PubMed 24599632
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Safety and Efficacy for Night Shift Therapy
- ClinicalTrials.gov ID
- NCT02032706
- Acronym / sponsor ID
- 201301
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, position therapy, snoring, positional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Advanced Brain Monitoring, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Posted 2 Mar 2016
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 is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
Detailed description
The protocol is designed to first evaluate the accuracy of supine vs. non-supine detection in 15 subjects (hereafter referred to as study 1). In study 2, patients who had completed a baseline polysomnography (PSG) with a minimum of four hours of sleep time were to wear the Night Shift for two nights without feedback to confirm their willingness to continue with the study, followed by 28 nights of vibro-tactile position therapy. A follow-up PSG was to be conducted as soon as possible to the completion of the 28-nights of treatment. During enrollment subjects were to complete pre-treatment questionnaires designed to measure daytime sleepiness, insomnia severity, depression, anxiety, and quality of life. The same instruments were completed post-treatment on the morning after the 28th night of treatment. Subjects completed daily logs to confirm device utilization and identify potential non-device related factors that could influence study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positional feedback | Experimental | Device: Deliver therapy when the supine position is detectedDeliver therapy when the supine position is detected |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Neck, back or should pain which would impact ability to sleep laterally each night
- Body mass index > 35
- suffering from neurological disorders which result in ticks or tremors
- diagnosed with congestive heart failure or chronic obstructive pulmonary disease
- suffered from a stroke within the previous 12 months
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 |
|---|---|---|
| Deliver therapy when the supine position is detectedAlso: Night ShiftApplication of vibrotactile feedback to the neck when the supine position is detected | Device | Positional feedback |
Primary outcome
Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events
Time frame: Four weeks
Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.
Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy
Time frame: 30-days
Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.
8 secondary outcomes
Confirmation That Night Shift Accurately Detects Supine Position
Time frame: baseline and 4-weeks later at follow up
Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant
Time frame: four weeks
Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback
Time frame: four weeks
Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA
Time frame: baseline and followup
Evaluate Impact of Positional Therapy on Quality of Life Scores
Time frame: four weeks
Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake
Time frame: baseline and follow-up
Assess the Accuracy of Night Shift's Measurement of Total Sleep Time
Time frame: one night
Assess the Accuracy of Night Shift Measurement of Sleep Efficiency
Time frame: one night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25126032Levendowski DJ, Seagraves S, Popovic D, Westbrook PR. Assessment of a neck-based treatment and monitoring device for positional obstructive sleep apnea. J Clin Sleep Med. 2014 Aug 15;10(8):863-71. doi: 10.5664/jcsm.3956.
- Background: PubMed 24599632Levendowski DJ, Veljkovic B, Seagraves S, Westbrook PR. Capability of a neck worn device to measure sleep/wake, airway position, and differentiate benign snoring from obstructive sleep apnea. J Clin Monit Comput. 2015 Feb;29(1):53-64. doi: 10.1007/s10877-014-9569-3. Epub 2014 Mar 6.
- Related InfoLink provided by the sponsor.
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
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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.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Daniel J Levendowski, MBA principal investigator
Advanced Brain Monitoring, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deliver therapy when the supine position is detected in people with Obstructive Sleep Apnea, run by Advanced Brain Monitoring, Inc. 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 0 inclusion and 9 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 1 Apr 2016. 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 2 Mar 2016). 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?
Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events (time frame: Four weeks). 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 NCT02032706, which also lists 2 linked publications.
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 1 Apr 2016.