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Validation of Safety and Efficacy for Night Shift Therapy

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Deliver therapy when the supine position is detected

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, position therapy, snoring, positional

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Complete Sleep Solutions

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positional feedback

Arm Description

Deliver therapy when the supine position is detected

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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).

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.

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

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.

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.

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.

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.

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

Full Information

NCT ID

NCT02032706

First Posted

January 8, 2014

Last Updated

March 4, 2016

Sponsor

Advanced Brain Monitoring, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02032706

Brief Title

Validation of Safety and Efficacy for Night Shift Therapy

Official Title

Validation of Safety and Efficacy for Night Shift Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advanced Brain Monitoring, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea, position therapy, snoring, positional

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Positional feedback

Arm Type

Experimental

Arm Description

Deliver therapy when the supine position is detected

Intervention Type

Device

Intervention Name(s)

Deliver therapy when the supine position is detected

Other Intervention Name(s)

Night Shift

Intervention Description

Application of vibrotactile feedback to the neck when the supine position is detected

Primary Outcome Measure Information:

Title

Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events

Description

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.

Time Frame

Four weeks

Title

Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy

Description

Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.

Time Frame

30-days

Secondary Outcome Measure Information:

Title

Confirmation That Night Shift Accurately Detects Supine Position

Description

Time Frame

baseline and 4-weeks later at follow up

Title

Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant

Description

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.

Time Frame

four weeks

Title

Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback

Description

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

Time Frame

four weeks

Title

Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA

Description

Time Frame

baseline and followup

Title

Evaluate Impact of Positional Therapy on Quality of Life Scores

Description

Time Frame

four weeks

Title

Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake

Description

Time Frame

baseline and follow-up

Title

Assess the Accuracy of Night Shift's Measurement of Total Sleep Time

Description

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.

Time Frame

one night

Title

Assess the Accuracy of Night Shift Measurement of Sleep Efficiency

Description

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

Time Frame

one night

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel J Levendowski, MBA

Organizational Affiliation

Advanced Brain Monitoring, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Complete Sleep Solutions

City

Murrieta

State/Province

California

ZIP/Postal Code

92563

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25126032

Citation

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.

Results Reference

background

PubMed Identifier

24599632

Citation

Levendowski 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.

Results Reference

background

Links:

URL

http://advancedbrainmonitoring.com/night-shift/

Description

Related Info

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Validation of Safety and Efficacy for Night Shift Therapy

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