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Validation of Safety and Efficacy for Night Shift Therapy

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ClinicalTrials.gov Identifier: NCT02032706
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : March 2, 2016
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Advanced Brain Monitoring, Inc.

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Deliver therapy when the supine position is detected Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation of Safety and Efficacy for Night Shift Therapy
Study Start Date : June 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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 Name: Night Shift




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032706


Locations
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United States, California
Complete Sleep Solutions
Murrieta, California, United States, 92563
Sponsors and Collaborators
Advanced Brain Monitoring, Inc.
Investigators
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Principal Investigator: Daniel J Levendowski, MBA Advanced Brain Monitoring, Inc.

Additional Information:
Publications:
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Responsible Party: Advanced Brain Monitoring, Inc.
ClinicalTrials.gov Identifier: NCT02032706     History of Changes
Other Study ID Numbers: 201301
First Posted: January 10, 2014    Key Record Dates
Results First Posted: March 2, 2016
Last Update Posted: April 1, 2016
Last Verified: June 2014
Keywords provided by Advanced Brain Monitoring, Inc.:
obstructive sleep apnea
position therapy
snoring
positional
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases