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

NCT ID: NCT04609618

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-08-26

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 .

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obstructive Sleep Apnea patients

Appscent device will discharge odor during the in lab night sleep

Group Type: EXPERIMENTAL

Appscent Device

Intervention Type: DEVICE

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

Interventions

Appscent Device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Y.A. Appscent Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sleep Lab

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

CLN001

Identifier Type: -

Identifier Source: org_study_id