Validation of Safety and Efficacy for Night Shift Therapy

March 4, 2016 updated by: Advanced Brain Monitoring, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Murrieta, California, United States, 92563
        • Complete Sleep Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

The inclusion criteria are:

  • be between the age of 18 and 75 years,
  • have been diagnosed with Obstructive Sleep Apnea (OSA) during polysomnography at a designated sleep center within 4 months of their enrollment,
  • have not received treatment with any OSA therapy for more than 3 days within the past month,
  • have an overall Apnea-Hypopnea Index (AHI) > 10 and hypopneas requiring >3% oxygen desaturation,
  • having a non-supine Apnea-Hypopnea Index (AHI) < 15 if Continuous Positive Airway Pressure has not been attempted,
  • have a overall AHI divided by the non-supine AHI > 1.5,
  • had an Epworth Sleepiness Score of 5 or more at the time of diagnosis and at the start of therapy,
  • Change in weight of no more than 5 pounds since the diagnostic PSG
  • access to a computer and the Internet
  • sleep is sometime between 8 P.M. to 9 A.M. Monday through Friday in the same bed

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Positional feedback
Deliver therapy when the supine position is detected
Device: Deliver therapy when the supine position is detected
Application of vibrotactile feedback to the neck when the supine position is detected
Other Names:
  • Night Shift

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Four weeks
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.
30-days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Confirmation That Night Shift Accurately Detects Supine Position
Time Frame: baseline and 4-weeks later at follow up
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).
baseline and 4-weeks later at follow up
Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant
Time Frame: four weeks
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.
four weeks
Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback
Time Frame: four weeks
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
four weeks
Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA
Time Frame: baseline and followup
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.
baseline and followup
Evaluate Impact of Positional Therapy on Quality of Life Scores
Time Frame: four weeks
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.
four weeks
Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake
Time Frame: baseline and follow-up
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.
baseline and follow-up
Assess the Accuracy of Night Shift's Measurement of Total Sleep Time
Time Frame: one night
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.
one night
Assess the Accuracy of Night Shift Measurement of Sleep Efficiency
Time Frame: one night
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
one night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Advanced Brain Monitoring, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel J Levendowski, MBA, Advanced Brain Monitoring, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201301

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