Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.

Obstructive Sleep Apnea Clinical Trial

Official title:

A Prospective, Self-controlled, Feasibility Study to Evaluate Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609618
• Other study ID #: CLN001
• Status: Completed
• Phase: Early Phase 1
• Start date: October 15, 2020
• Est. completion date: August 26, 2021

Study information

• Verified date: January 2023
• Source: Y.A. Appscent Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 26, 2021
• Est. primary completion date: August 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Appscent Device
computer-controlled, low pressure compressed air based, with disposable odorant capsules solution provided an odor environment at the nose,

Locations

Country	Name	City	State
Israel	Sleep Lab	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Y.A. Appscent Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety event frequency	Device or treatment-related adverse events.	3 weeks
Secondary	Sleepiness effect	Overall sleepiness change measured by ESS	2 weeks