The Snore-Breaker as a treatment for positional sleep apnea

The Snore-Breaker as a treatment for positional sleep apnea - The Snore-Breaker as a treatment for positional sleep apnea

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37780

Enrollment

Registered

2012-04-03

Start date

2012-04-12

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructieve slaap apneu stoornis (OSAS) OSAS Sleep apnea

Interventions

The Snore-Breaker: The Snore-Breaker (SB) is a positional therapy. The device consists of an adjustable elastic band which have to be tied around the waist. A green disc will be attached to this ela

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Positional sleep apnea. With a total apnea-hypoapnea index (AHI) of 5 or higher. An AHI in supine position of 5 or higher. An AHI in other sleeping positions of 10 or lower. The AHI in supine position has to be at least two time as big as the AHI in other positions.

Exclusion criteria

Exclusion criteria: People who already have another therapy for their sleep apnea (such as a MAD or CPAP) and who have AHI scores which do not meet the inclusion criterea will be excluded. Also, people who (continually) use sleepmedication or alcohol- and drugsabusers will be excluded.

Design outcomes

Primary

Measure	Time frame
Primary dependent variable: The primary study variable is the suitability of the Snore-Breaker as positional therapy for the treatment of OSA. A significant decrease in AHI (or even normalization of the AHI, an AHI	—

Secondary

Measure	Time frame
Secondary research variables: The secondary variables include 1. the possible reduction of subjective OSA symptoms (excessive daytime sleepiness (measured by the ESS), snoring, excessive sweating at night, apneas, waking up coughing, waking up with a dry mouth / throat, difficulty breahting at night, waking up with a sour taste in the mouth, morning headaches (measured with the SLEEP-50)), subjective sleep quality (measured using the SLEEP-50), socially and functionally disabling consequences of OSA (as measured by SAQLI) and improving the Quality of Life (measured by the SF-36). 2. The possible learning effect (subjects sleeping less on their back as the treatmentperiod progresses) that occurs during use of the Snore-Breaker (measured by the data feedback from the SB) and 3. If the AHI, time in the supine position, the total arousal index, subjective symptoms and QoL significantly more improve with the vibrating-SB in comparison with the non-vibrating (placebo) SB and whether the vibrating SB triggers a significantly greater learning effect and is more user-friendly and has a greater compliance. Epworth Sleepiness Scale (ESS): The ESS (Johns et al, 1992) measures the degree of daytime sleepiness (excessive daytime sleepiness; EDS). EDS is a common symptom of OSA. In this 8-item questionnaire the probability that the subject during the past two weeks has a tendency to doze is measured. The situations range from monotonic situations to activities where a high degree of attention is required. The interpretation of the ESS score is as follows: a score of 0-8 is considered normal, where as score of 9-12 displays mild sleepiness, 13-16 moderate and 17-24 severe excessive sleepiness. SLEEP-50: The SLEEP-50 (Spoormaker et al, 2005) is a 50-item sleep diagnosis questionnaire in which symptoms of various sleep disorders are mentioned. Among others; symptoms of sleep apnea, insomnia, narcolepsy, RLS / PLMD, a circadian rhythm disorder, somnabulis	—

Measure

Time frame

Secondary research variables: The secondary variables include 1. the possible reduction of subjective OSA symptoms (excessive daytime sleepiness (measured by the ESS), snoring, excessive sweating at night, apneas, waking up coughing, waking up with a dry mouth / throat, difficulty breahting at night, waking up with a sour taste in the mouth, morning headaches (measured with the SLEEP-50)), subjective sleep quality (measured using the SLEEP-50), socially and functionally disabling consequences of OSA (as measured by SAQLI) and improving the Quality of Life (measured by the SF-36). 2. The possible learning effect (subjects sleeping less on their back as the treatmentperiod progresses) that occurs during use of the Snore-Breaker (measured by the data feedback from the SB) and 3. If the AHI, time in the supine position, the total arousal index, subjective symptoms and QoL significantly more improve with the vibrating-SB in comparison with the non-vibrating (placebo) SB and whether the vibrating SB triggers a significantly greater learning effect and is more user-friendly and has a greater compliance. Epworth Sleepiness Scale (ESS): The ESS (Johns et al, 1992) measures the degree of daytime sleepiness (excessive daytime sleepiness; EDS). EDS is a common symptom of OSA. In this 8-item questionnaire the probability that the subject during the past two weeks has a tendency to doze is measured. The situations range from monotonic situations to activities where a high degree of attention is required. The interpretation of the ESS score is as follows: a score of 0-8 is considered normal, where as score of 9-12 displays mild sleepiness, 13-16 moderate and 17-24 severe excessive sleepiness. SLEEP-50: The SLEEP-50 (Spoormaker et al, 2005) is a 50-item sleep diagnosis questionnaire in which symptoms of various sleep disorders are mentioned. Among others; symptoms of sleep apnea, insomnia, narcolepsy, RLS / PLMD, a circadian rhythm disorder, somnabulis

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)