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

NCT04609618 | Completed Early Phase 1

• 1 other identifier: CLN001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Safety event frequency

  Device or treatment-related adverse events.

  3 weeks

Secondary Outcomes (1)

• Sleepiness effect

  2 weeks

Study Arms (1)

Obstructive Sleep Apnea patients

EXPERIMENTAL

Appscent device will discharge odor during the in lab night sleep

Device: Appscent Device

Interventions

Appscent Device DEVICE

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

Obstructive Sleep Apnea patients

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OSA diagnosed; AHI≥20
• Male and Female Aged 40 to 70 years old
• 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
• BMI\< 35
• Patient is willing and able to give his/her written informed consent

You may not qualify if:

• Chronic lung disease (including Asthma and COPD)
• Congestive Heart Failure
• Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment
• History of severe nasal allergies or sinusitis or difficulty breathing through the nose
• Persistent blockage of one or both nostrils
• Any previous operation or trauma to the nose
• Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure
• Any use of antipsychotic, Hypnotic drugs
• Major neurological diagnosis
• Active malignant disease including chemotherapy or radiotherapy treatment
• Pregnant or lactating women
• Drug abuse
• Medical history of epilepsy

Sponsors & Collaborators

• Y.A. Appscent Ltd.: lead

Study Sites (1)

Sleep Lab

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, self-controlled, feasibility study.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: October 15, 2020
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

IL (1)