NCT04211350

Brief Summary

Comparison of the NightBalance Sleep Position Trainer (SPT) to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA). Primary Objective: Efficacy and Adherence of the SPT over 3 months of use compared to PAP for the treatment of POSA. The study is run from centers in France, the UK and Germany.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
3 countries

18 active sites

Status
terminated

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

Study Start

First participant enrolled

February 4, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

4 years

First QC Date

December 23, 2019

Last Update Submit

February 6, 2024

Conditions

Obstructive Sleep Apnea

Keywords

Positional Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

  • Change of Apnea-Hypopnea Index (AHI)

    Efficacy will be measured as Change of Apnea-Hypopnea Index (AHI) from baseline to 3 months and from 3 months to 6 months (NightBalance SPT non-inferior to PAP)

    Baseline,3 months and 6 months

  • Difference of the total hours medical device use between each treatment arm

    Adherence will be measured as the difference between the total hours medical device use from baseline to 3 months and from 3 months to 6 months (NightBalance SPT superior to PAP)

    3 months and 6 months

Secondary Outcomes (7)

  • Daytime Sleepiness

    Baseline,3 months and 6 months

  • Impact of sleepiness on activities of daily living

    Baseline,3 months and 6 months

  • Health related quality of life

    Baseline,3 months and 6 months

  • Fatigue

    Baseline,3 months and 6 months

  • Quality of life utilizing SF-36

    Baseline,3 months and 6 months

  • +2 more secondary outcomes

Study Arms (2)

NightBalance Sleep Position Therapy

EXPERIMENTAL

NightBalance Sleep Position Trainer (SPT) avoids POSA patients from sleeping on their back by delivering a vibrational stimulus, via a small device which is worn in a chest strap during sleep, each time the patient rolls to their back. This prompts the patient to roll over onto their side.

Device: NightBalance Sleep Position Trainer (SPT)

Positive Airway Pressure (APAP)

EXPERIMENTAL

Automatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.

Device: Automatic Positive Airway Pressure (APAP)

Interventions

NightBalance Sleep Position Trainer (SPT)DEVICE

NightBalance Sleep Position Trainer (SPT) avoids POSA patients from sleeping on their back by delivering a vibrational stimulus, via a small device which is worn in a chest strap during sleep, each time the patient rolls to their back. This prompts the patient to roll over onto their side.

NightBalance Sleep Position Therapy
Automatic Positive Airway Pressure (APAP)DEVICE

Automatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.

Positive Airway Pressure (APAP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is adult
  • Either: Treatment naïve, or PAP non-complier (defined as current AAP user with \<3 hours per night in the last 3 months per compliance download), and willing to use the APAP device per protocol
  • Diagnosis of POSA meeting all the following criteria per control PSG within 6 months of screening: AHI of \>15 during PSG with symptoms of sleepiness per Investigator discretion, or AHI of \>15 during respiratory polygraphy with comorbidities (e.g. atrial fibrillation, resistant hypertension, etc.)
  • Supine AHI at least twice the lateral AHI
  • Lateral AHI \<10
  • Supine time \>30% and \<70%
  • Understands the study protocol and is willing and able to comply with study requirements and sign informed consent. APAP non-compliant subjects must be willing to use their APAP device per protocol.

You may not qualify if:

  • Prior or current therapy or treatment for OSA (for Treatment naïve group); Greater than an average of 3 hours per night of APAP use (in the APAP non-complier group)
  • A female of child-bearing potential that is pregnant or intends to become pregnant
  • Any unstable or severe medical condition of any organ system that at the discretion of the site Principal Investigator (PI) might affect the patient's participation in the study or generalization of treatment results
  • Taking medication that at the discretion of the site Principal Investigator (PI) might affect the patient's participation in the study or generalization of treatment results
  • 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), per subject report
  • 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 (18)

Centre Hospitalier Universitaire Angers

Angers, France

Location

CHU Grenoble Alpes

Grenoble, 38000, France

Location

Centre Hospitalier Universitaire Bordeaux

Paris, France

Location

Hôpital Bichat - Claude-Bernard

Paris, France

Location

Hôpital Universitaire Pitié - Salpêtrière (UPMC)

Paris, France

Location

Hopital Foch, Suresnes

Suresnes, France

Location

Zentrum für Schlafmedizin Berlin

Berlin, Germany

Location

Klinikum Rechts der Isar

München, Germany

Location

Schlafmedizinisches Zentrum Regensburg

Regensburg, Germany

Location

Praxis Dr. Holger Hein

Reinbek, Germany

Location

Helios Kliniken

Schwerin, Germany

Location

Hospital Bethanien Solingen

Solingen, Germany

Location

Royal Papworth Hospital

Cambridge, United Kingdom

Location

Royal infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Prince Philip Hospital

Llanelli, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust (GSTT)

London, United Kingdom

Location

Royal Preston Hospital

Preston, United Kingdom

Location

North Tyneside General Hospital

Tyneside, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2019

First Posted

December 26, 2019

Study Start

February 4, 2019

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

GB(6)DE(6)FR(6)