Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Appscent Device
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Sleep Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Obstructive Sleep Apnea patients
Arm Description
Appscent device will discharge odor during the in lab night sleep
Outcomes
Primary Outcome Measures
Safety event frequency
Device or treatment-related adverse events.
Secondary Outcome Measures
Sleepiness effect
Overall sleepiness change measured by ESS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04609618
Brief Title
Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
August 26, 2021 (Actual)
Study Completion Date
August 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Y.A. Appscent Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Prospective, self-controlled, feasibility study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obstructive Sleep Apnea patients
Arm Type
Experimental
Arm Description
Appscent device will discharge odor during the in lab night sleep
Intervention Type
Device
Intervention Name(s)
Appscent Device
Intervention Description
computer-controlled, low pressure compressed air based, with disposable odorant capsules solution provided an odor environment at the nose,
Primary Outcome Measure Information:
Title
Safety event frequency
Description
Device or treatment-related adverse events.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Sleepiness effect
Description
Overall sleepiness change measured by ESS
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Sleep Lab
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.
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