Sleep Apnea Syndromes
Conditions
Keywords
Positional Sleep Apnea, Positional Obstructive Sleep Apnea, POSA, OSA, Obstructive Sleep Apnea, Sleep Apnea
Brief summary
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).
Detailed description
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of POSA. The Primary Objective of the study is to demonstrate non-inferiority of treatment with the SPT as compared to APAP.
Interventions
Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.
DEVICEAutomated Adjusting Positive Airway Pressure (APAP)
Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.
Sponsors
NightBalance
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The technician scoring the polysomnograms will be unaware of previous PSG results from the patient to the best of their ability (ie: will not look back in their records for the purpose of reviewing their previous PSGs prior to scoring).
Intervention model description
6 week crossover study, randomized to order of treatment
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is between the ages of 20 and 80. 2. Diagnosis of POSA meeting all the following criteria per in-lab control PSG (performed within 3 months of screening): * Total AHI \>15, or AHI \>10 and \<15 with ESS \>10 * Supine AHI at least twice the non-supine AHI * Non-supine AHI \<10 (\<5 in mild patients) * Supine time \>40% and \<60% 3. Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
Exclusion criteria
1. Prior surgery to treat OSA (such as UPPP), or prior or current therapy or treatment for OSA, with the exception of PAP being used for split night PSG only. 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 including congestive heart failure, COPD, renal failure, neuromuscular disease, or at the discretion of the site Principal Investigator (PI). 4. Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, opiates, sedating antidepressants, and anticonvulsants. 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). 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI, events/hr) | 6 week | Non-inferiority of SPT vs. APAP (measured by events/hr during in lab polysomnography) |
| Adherence (minutes of device use per night) | 6 week | Non-inferiority of SPT vs. APAP (calculated by number of minutes of objective device use per night) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction (Comfort, Satisfaction) assessed by Visual Analog Scale (VAS) | 6 week | SPT vs. APAP |
| Oxygen Desaturation Index (3%) | 6 week | SPT vs. APAP |
| Total Sleep Time (minutes) | 6 week | SPT vs. APAP (measured by in lab polysomnography) |
| Sleep Onset Latency (minutes) | 6 week | SPT vs. APAP (measured by in lab polysomnography) |
| Sleep Efficiency (%) | 6 week | SPT vs. APAP (measured by in lab polysomnography) |
| Arousal Index | 6 week | SPT vs. APAP (measured by in lab polysomnography) |
| Sleep Stages (%) | 6 week | SPT vs. APAP (measured by in lab polysomnography) |
| Sleep Position (%) | 6 week | SPT vs. APAP (measured by in lab polysomnography) |
| Epworth Sleepiness Scale (ESS) | 6 week | SPT vs. APAP |
| Functional Outcomes of Sleep Questionnaire (FOSQ) | 6 week | SPT vs. APAP |
| SF-36 | 6 week | SPT vs. APAP |
| Mean Disease Alleviation (MDA) (%) | 6 weeks | SPT vs. APAP (MDA (%) is calculated by the product of the objective adherence (from SPT and APAP download), adjusted for total sleep time (X-axis), combined with therapeutic efficacy (AHI from the respective treatment night, Y-axis), divided by 100.) |
| Adverse Events | 6 weeks | SPT vs. APAP, frequency, seriousness, severity and device relationship will be summarized. |
Countries
United States
Outcome results
None listed