Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
14 participants
INTERVENTIONAL
2019-02-04
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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NightBalance Sleep Position Therapy
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 Trainer (SPT)
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.
Positive Airway Pressure (APAP)
Automatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.
Automatic Positive Airway Pressure (APAP)
Automatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.
Interventions
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NightBalance Sleep Position Trainer (SPT)
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)
Automatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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.)
4. Supine AHI at least twice the lateral AHI
5. Lateral AHI \<10
6. Supine time \>30% and \<70%
7. 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.
Exclusion Criteria
2. A female of child-bearing potential that is pregnant or intends to become pregnant
3. 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
4. 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
5. Oxygen use
6. The presence of any other sleep disorder (central sleep apnea (CSA \>5), periodic limb movement disorder (PLMAI \>15), clinical diagnosis of insomnia or narcolepsy)
7. Excessive alcohol consumption (\>21 drinks/week)
8. The use of any illegal drug(s), per subject report
9. Night or rotating shift work
10. Severe claustrophobia
11. Shoulder, neck, or back complaints that restrict sleeping position
12. Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position
18 Years
ALL
No
Sponsors
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Philips Clinical & Medical Affairs Global
INDUSTRY
Responsible Party
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Locations
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Centre Hospitalier Universitaire Angers
Angers, , France
CHU Grenoble Alpes
Grenoble, , France
Centre Hospitalier Universitaire Bordeaux
Paris, , France
Hôpital Bichat - Claude-Bernard
Paris, , France
Hôpital Universitaire Pitié - Salpêtrière (UPMC)
Paris, , France
Hopital Foch, Suresnes
Suresnes, , France
Zentrum für Schlafmedizin Berlin
Berlin, , Germany
Klinikum Rechts der Isar
München, , Germany
Schlafmedizinisches Zentrum Regensburg
Regensburg, , Germany
Praxis Dr. Holger Hein
Reinbek, , Germany
Helios Kliniken
Schwerin, , Germany
Hospital Bethanien Solingen
Solingen, , Germany
Royal Papworth Hospital
Cambridge, , United Kingdom
Royal infirmary of Edinburgh
Edinburgh, , United Kingdom
Prince Philip Hospital
Llanelli, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust (GSTT)
London, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
North Tyneside General Hospital
Tyneside, , United Kingdom
Countries
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Other Identifiers
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2018-A02141-54
Identifier Type: OTHER
Identifier Source: secondary_id
ISRCTN16170657
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-2018-001
Identifier Type: -
Identifier Source: org_study_id
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