Comparison of the NightBalance Lunoa to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)

• Register: ISRCTN
• Last refreshed on: 3 March 2020
• Main ID: ISRCTN16170657
• Date of registration: 27/04/2018
• Prospective Registration: Yes
• Primary sponsor: Philips
• Public title: Comparison of the NightBalance Lunoa to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)
• Scientific title: A Multi-center, Prospective, Randomized Crossover Study with the NightBalance Lunoa SPT Compared to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)
• Date of first enrolment: 01/08/2018
• Target sample size: 150
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN16170657
• Study type: Interventional
• Study design: Multi-center interventional prospective randomised 3-month crossover study (Treatment)
• Phase: Not Applicable

Countries of recruitment

France, Germany, United Kingdom

Contacts

• Name: Ellen Dutman

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject is adult
2. Either:
2.1. Treatment naïve, or
2.2. 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:
3.1. 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.)
3.2. Supine AHI at least twice the lateral AHI
3.3. Lateral AHI <10
3.4. Supine time >30% and <70%
4. 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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Sleep apnea
Respiratory
Positional obstructive sleep apnea

Intervention(s)

Participants are randomised to receive either Automatic Positive Airway Pressure (APAP), the gold standard treatment for Obstructive Sleep Apnea (OSA), or Lunoa Sleep Position Therapy for a three month period, stratified by site and treatment group with 50% of the patients in each arm.
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.

At baseline and after each treatment, patients undergo a polysomnography test and complete a battery of questionnaires. During each treatment period, patients complete a healthcare utilization diary and report any adverse events. Upon conclusion of each treatment period, patients have the data downloaded from their treatment device.

Primary Outcome(s)

1. Severity of sleep apnea is measured using apnea-hypopnea index (AHI) measured with polysomnography at baseline and at the end of each 3-month treatment arm
2. Adherence is measured by downloading the data from the devices at the end of each 3-month treatment period

Secondary Outcome(s)

1. Daytime sleepiness is measured using ESS at baseline and at the end of each 3 month treatment arm.
2. Impact of sleepiness on activities of daily living is measured using FOSQ at baseline and at the end of each 3 month treatment arm.
3. Health related quality of life is measured using EQ-5D at baseline and at the end of each 3 month treatment arm.
4. Fatigue is measured using Pichot Fatigue Scale at baseline and at the end of each 3 month treatment arm.
5. Quality of life is measured using SF-36 at baseline and at the end of each 3 month treatment arm.
6. Patient Comfort and Satisfaction is measured using Likert scales at baseline and at the end of each 3 month treatment arm.
7. 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
9. Health Economics and Resource Utilization are assessed using healthcare utilization diary which is completed by patients during each 3-month treatment arm

Secondary ID(s)

NCT04211350

EU-2018-001

Source(s) of Monetary Support

Philips

Ethics review

Status:
Approval date:
Contact:

Approved 14/08/2018, Cambridge East Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; 0207 1048056; [e-mail]), ref: 18/EE/0201

Results

• Results available: Yes
• Date Completed: 31/01/2021