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SLEEP ON Your SIDE (SOS) Study (SOS)

Primary Purpose

Obstructive Sleep Apnea

Status
Suspended
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NightBalance Sleep Position Trainer (SPT)
Automatic Positive Airway Pressure (APAP)
Sponsored by
Philips Clinical & Medical Affairs Global
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Positional Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is adult
  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:

  1. 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)
  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

Sites / Locations

  • Centre Hospitalier Universitaire Angers
  • CHU Grenoble Alpes
  • Centre Hospitalier Universitaire Bordeaux
  • Hôpital Bichat - Claude-Bernard
  • Hôpital Universitaire Pitié - Salpêtrière (UPMC)
  • Hopital Foch, Suresnes
  • Zentrum für Schlafmedizin Berlin
  • Klinikum Rechts der Isar
  • Schlafmedizinisches Zentrum Regensburg
  • Praxis Dr. Holger Hein
  • Helios Kliniken
  • Hospital Bethanien Solingen
  • Royal Papworth Hospital
  • Royal infirmary of Edinburgh
  • Prince Philip Hospital
  • Guy's and St Thomas' NHS Foundation Trust (GSTT)
  • Royal Preston Hospital
  • North Tyneside General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NightBalance Sleep Position Therapy

Positive Airway Pressure (APAP)

Arm Description

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) is a pump that provides a positive flow of air to keep the airway open.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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.
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.
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.
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.
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.
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
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.

Full Information

First Posted
December 23, 2019
Last Updated
January 23, 2023
Sponsor
Philips Clinical & Medical Affairs Global
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1. Study Identification

Unique Protocol Identification Number
NCT04211350
Brief Title
SLEEP ON Your SIDE (SOS) Study
Acronym
SOS
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Global recall of the comparator device
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Positional Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NightBalance Sleep Position Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Positive Airway Pressure (APAP)
Arm Type
Experimental
Arm Description
Automatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.
Intervention Type
Device
Intervention Name(s)
NightBalance Sleep Position Trainer (SPT)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Automatic Positive Airway Pressure (APAP)
Intervention Description
Automatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.
Primary Outcome Measure Information:
Title
Change of Apnea-Hypopnea Index (AHI)
Description
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)
Time Frame
Baseline,3 months and 6 months
Title
Difference of the total hours medical device use between each treatment arm
Description
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)
Time Frame
3 months and 6 months
Secondary Outcome Measure Information:
Title
Daytime Sleepiness
Description
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.
Time Frame
Baseline,3 months and 6 months
Title
Impact of sleepiness on activities of daily living
Description
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.
Time Frame
Baseline,3 months and 6 months
Title
Health related quality of life
Description
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.
Time Frame
Baseline,3 months and 6 months
Title
Fatigue
Description
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.
Time Frame
Baseline,3 months and 6 months
Title
Quality of life utilizing SF-36
Description
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.
Time Frame
Baseline,3 months and 6 months
Title
Mean Disease Alleviation
Description
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
Time Frame
3 months and 6 months
Title
Health Economics and Resource Utilization
Description
Health Economics and Resource Utilization are assessed using healthcare utilization diary which is completed by patients during each 3-month treatment arm.
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Centre Hospitalier Universitaire Angers
City
Angers
Country
France
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Centre Hospitalier Universitaire Bordeaux
City
Paris
Country
France
Facility Name
Hôpital Bichat - Claude-Bernard
City
Paris
Country
France
Facility Name
Hôpital Universitaire Pitié - Salpêtrière (UPMC)
City
Paris
Country
France
Facility Name
Hopital Foch, Suresnes
City
Suresnes
Country
France
Facility Name
Zentrum für Schlafmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Klinikum Rechts der Isar
City
München
Country
Germany
Facility Name
Schlafmedizinisches Zentrum Regensburg
City
Regensburg
Country
Germany
Facility Name
Praxis Dr. Holger Hein
City
Reinbek
Country
Germany
Facility Name
Helios Kliniken
City
Schwerin
Country
Germany
Facility Name
Hospital Bethanien Solingen
City
Solingen
Country
Germany
Facility Name
Royal Papworth Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Royal infirmary of Edinburgh
City
Edinburgh
Country
United Kingdom
Facility Name
Prince Philip Hospital
City
Llanelli
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust (GSTT)
City
London
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
Country
United Kingdom
Facility Name
North Tyneside General Hospital
City
Tyneside
Country
United Kingdom

12. IPD Sharing Statement

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