Obstructive Sleep Apnea
Conditions
Brief summary
Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). The major disadvantage of CPAP is the relatively low compliance. Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake.
Detailed description
Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. OSA lead to desaturation and often lead to an arousal. Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems. The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). CPAP acts as a pneumatic splint that elevates and maintains a constant pressure along the upper airway during inspiration and expiration that prevents airway collapse. The major disadvantage of CPAP is the relatively low compliance. Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake. Odorants transiently presented during sleep induced a respiratory rejection type response, this suggests that manipulating the respiratory system without waking is viable .
Interventions
DEVICEAppscent Device
computer-controlled, low pressure compressed air based, with disposable odorant capsules solution provided an odor environment at the nose,
Sponsors
Y.A. Appscent Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, self-controlled, feasibility study.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. OSA diagnosed; AHI≥20 2. Male and Female Aged 40 to 70 years old 3. Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study 4. BMI\< 35 5. Patient is willing and able to give his/her written informed consent
Exclusion criteria
1. Chronic lung disease (including Asthma and COPD) 2. Congestive Heart Failure 3. Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment 4. History of severe nasal allergies or sinusitis or difficulty breathing through the nose 5. Persistent blockage of one or both nostrils 6. Any previous operation or trauma to the nose 7. Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure 8. Any use of antipsychotic, Hypnotic drugs 9. Major neurological diagnosis 10. Active malignant disease including chemotherapy or radiotherapy treatment 11. Pregnant or lactating women 12. Drug abuse 13. Medical history of epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety event frequency | 3 weeks | Device or treatment-related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleepiness effect | 2 weeks | Overall sleepiness change measured by ESS |
Countries
Israel
Outcome results
None listed