SLEEP ON Your SIDE (SOS) Study

Obstructive Sleep Apnea Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04211350
• Other study ID #: EU-2018-001
• Secondary ID: 2018-A02141-54IS
• Status: Terminated
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The study is run from centers in France, the UK and Germany.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	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
Germany	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
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline,3 months and 6 months
Secondary	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.	Baseline,3 months and 6 months
Secondary	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.	Baseline,3 months and 6 months
Secondary	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.	Baseline,3 months and 6 months
Secondary	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.	Baseline,3 months and 6 months
Secondary	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	3 months and 6 months
Secondary	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.	3 months and 6 months