NCT03061071

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

February 13, 2017

Last Update Submit

August 20, 2018

Conditions

Sleep Apnea Syndromes

Keywords

Positional Sleep ApneaPositional Obstructive Sleep ApneaPOSAOSAObstructive Sleep ApneaSleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Adherence (minutes of device use per night)

    Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night)

    6 week

  • Apnea-Hypopnea Index (AHI, events/hr)

    Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography)

    6 week

Secondary Outcomes (13)

  • Epworth Sleepiness Scale (ESS)

    6 week

  • Functional Outcomes of Sleep Questionnaire (FOSQ)

    6 week

  • SF-36

    6 week

  • Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS)

    6 week

  • Oxygen Desaturation Index (3%)

    6 week

  • +8 more secondary outcomes

Study Arms (2)

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.

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.

Device: NightBalance Sleep Position Trainer (SPT)Device: Automated Adjusting Positive Airway Pressure (APAP)

Interventions

NightBalance Sleep Position Trainer (SPT)DEVICE

Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.

Randomized to APAP First: SPT SecondRandomized to SPT First: APAP Second
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.

Randomized to APAP First: SPT SecondRandomized to SPT First: APAP Second

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Sleep Med Inc., AZ

Glendale, Arizona, 85306, United States

Location

Sleep Disorders at Magnolia Park

Gainesville, Florida, 32606, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40218, United States

Location

Center for Sleep and Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St. Luke's Sleep Medicine and Research Center

Chesterfield, Missouri, 63017, United States

Location

Clayton Sleep Institute

Maplewood, Missouri, 63143, United States

Location

Med One Sleep

Fayetteville, North Carolina, 28304, United States

Location

Pearl Clinical Research

Paoli, Pennsylvania, 19301, United States

Location

SleepMed of South Carolina

Columbia, South Carolina, 29201, United States

Location

Related Publications (1)

  • 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.

    PMID: 31383231DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Richard B Berry, MD

    UF Health Sleep Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The technician scoring the polysomnograms will be unaware of previous PSG results from the patient to the best of their ability (ie: will not look back in their records for the purpose of reviewing their previous PSGs prior to scoring).
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 6 week crossover study, randomized to order of treatment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 23, 2017

Study Start

March 1, 2017

Primary Completion

July 12, 2018

Study Completion

July 12, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(11)