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Obstructive Sleep ApneaSOSNCT04211350

SLEEP ON Your SIDE (SOS) Study

A study testing NightBalance Sleep Position Trainer (SPT) and Automatic Positive Airway Pressure (APAP) in people with Obstructive Sleep Apnea, run by Philips Clinical & Medical Affairs Global at 18 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
NightBalance Sleep Position Trainer (SPT) and Automatic Positive Airway Pressure (APAP)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
18 sitesin 3 countries
Study dates
4 Feb 2019to 31 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

France6 sites

  • Centre Hospitalier Universitaire Angers

    Angers

  • CHU Grenoble Alpes

    Grenoble, 38000

  • Centre Hospitalier Universitaire Bordeaux

    Paris

  • Hôpital Bichat - Claude-Bernard

    Paris

  • Hôpital Universitaire Pitié - Salpêtrière (UPMC)

    Paris

  • Hopital Foch, Suresnes

    Suresnes

Other trials in France

Germany6 sites

  • Zentrum für Schlafmedizin Berlin

    Berlin

  • Klinikum Rechts der Isar

    München

  • Schlafmedizinisches Zentrum Regensburg

    Regensburg

  • Praxis Dr. Holger Hein

    Reinbek

  • Helios Kliniken

    Schwerin

  • Hospital Bethanien Solingen

    Solingen

Other trials in Germany

United Kingdom6 sites

  • Royal Papworth Hospital

    Cambridge

  • Royal infirmary of Edinburgh

    Edinburgh

  • Prince Philip Hospital

    Llanelli

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

    London

  • Royal Preston Hospital

    Preston

  • North Tyneside General Hospital

    Tyneside

Other trials in United Kingdom

About this study

Official title: A Multi-center, Prospective, Randomized Crossover Study With the NightBalance SPT Compared to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)

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.

Read the detailed description

Participants are randomly allocated to receive one of two treatments, either Automatic Positive Airway Pressure (APAP) or NightBalance Sleep Position Therapy for a three month period. Participants are sent home with instructions to use that device nightly at home for three months. After three months of using the first device, they return to the doctor for assessment of the efficacy of the device using a sleep test and the compliance read from the device. Upon conclusion of the first three month treatment period, patients receive the alternative treatment for a further three months. At the end of the second three month period, participants return to their doctor again to assess the efficacy of the last device and read the compliance. Before any treatment and after each treatment, patients undergo a sleep test and complete some questionnaires. During each treatment period, patients complete a healthcare utilization diary and report any problems.

Being tested
NightBalance Sleep Position Trainer (SPT), Automatic Positive Airway Pressure (APAP)
Keywords
Positional Obstructive Sleep Apnea
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT04211350
Study groupRoleWhat they receive
NightBalance Sleep Position TherapyExperimentalNightBalance 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.
Receives: Device: NightBalance Sleep Position Trainer (SPT)
Positive Airway Pressure (APAP)ExperimentalAutomatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.
Receives: Device: Automatic Positive Airway Pressure (APAP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline,3 months and 6 months

  2. 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)

    Measured: 3 months and 6 months

Secondary outcomes (7)

  1. Daytime Sleepiness

    Daytime sleepiness is measured using Epworth Sleepiness Scale (ESS). Epworth Sleepiness Scale (ESS), has a minimum value 0, maximum value 24 with higher values indicate worsening daytime sleepiness.

    Measured: Baseline,3 months and 6 months

  2. Impact of sleepiness on activities of daily living

    Impact of sleepiness on activities of daily living is measured using Functional Outcomes of Sleep Questionnaire (FOSQ). The FOSQ is a sleep related quality of life is measured across five dimensions; activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome. Each rate the difficulty of performing a given activity on a 4-point scale, min value 0, max value 4. Low scores indicate no difficulty, higher scores extreme difficulty.

    Measured: Baseline,3 months and 6 months

  3. Health related quality of life

    Health related quality of life is measured using EQ-5D at baseline and at the end of each 3 month treatment arm. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Responses are coded as single-digit numbers. The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state with lower scores indicting worsening health status and higher values improved health status.

    Measured: Baseline,3 months and 6 months

  4. Fatigue

    Fatigue is measured using Pichot Fatigue Scale at baseline and at the end of each 3 month treatment arm. The Pichot Fatigue Scale is an 8 question survey in which is answered 0 to 4 with a maximum score of 32. A score above 22 reveals excessive fatigue, patients may suffer from inefficient sleep.

    Measured: Baseline,3 months and 6 months

  5. Quality of life utilizing SF-36

    Quality of life is measured using SF-36 at baseline and at the end of each 3 month treatment arm. The 36-Item Short Form Health Survey (SF-36) is an indicator of overall health status. It has the following sections: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health.

    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. The lower scores mean more disability, and higher scores mean less disability.

    Measured: Baseline,3 months and 6 months

  6. Mean Disease Alleviation

    Mean Disease Alleviation is calculated using the AHI and adherence data at the end of each 3-month treatment arm 8. Adverse events are recorded at the end of each 3-month treatment arm

    Measured: 3 months and 6 months

  7. Health Economics and Resource Utilization

    Health Economics and Resource Utilization are assessed using healthcare utilization diary which is completed by patients during each 3-month treatment arm.

    Measured: 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start4 Feb 2019
  3. Primary completion31 Jan 2023
  4. Study completion31 Jan 2023

Why it stopped: Global recall of the comparator device

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04211350
Sponsor's protocol ID
EU-2018-001
Other IDs
2018-A02141-54, ISRCTN16170657
Acronym
SOS
Status last verified
Feb 2024
First submitted
23 Dec 2019
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing NightBalance Sleep Position Trainer (SPT) and Automatic Positive Airway Pressure (APAP) in people with Obstructive Sleep Apnea, run by Philips Clinical & Medical Affairs Global at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Global recall of the comparator device). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Apnea-Hypopnea Index (AHI) (time frame: Baseline,3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04211350.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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