Mild Obstructive Sleep ApneaNCT07492420
MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
A study testing MedCline Sleep System in people with Mild Obstructive Sleep Apnea, run by Amenity Health, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Obstructive Sleep Apnea
- What is being tested?
- MedCline Sleep System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis with mild obstructive sleep apnea (AHI 5-14.9)
- PSG or HST performed within last 24 months
- Individuals aged 18 or older
- Must routinely sleep on a standard mattress and must be able to accommodate the width of the MedCline Sleep System (30")
- Must be in overall good health, with no significant medical conditions that would interfere with the study procedures or the ability to sleep safely using the MedCline Sleep System
- Ability to provide written informed consent in accordance with IRB principles
- Must be stable on any medications for at least 3 months prior to the date of consent
Who cannot join
- Diagnosis of moderate to severe OSA (AHI >15) or central sleep apnea
- Has undergone surgical procedures for sleep apnea within the last six months
- Clinically significant cardiac or respiratory conditions that may interfere with the study intervention or outcomes.
- Chronic pain or musculoskeletal disorders, e.g., spinal deformities, scoliosis, kyphosis, back injuries, spinal compressions, or injuries that may affect their ability to sleep comfortably in a lateral position
- Pregnant or planning to become pregnant during study period
- Any conditions or circumstances that require frequent night-time awakenings (e.g., nocturia, caregiving responsibilities, or other health issues)
- Unable or unwilling to use the MedCline Sleep System as required by the study protocol
- Currently using substances or medications known to significantly alter sleep architecture or respiratory function (e.g., sedatives, narcotics, or alcohol dependency)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.
Read the detailed description
OSA is a common sleep disorder characterized by partial or complete obstruction of the upper airway during sleep that leads to intermittent pauses in breathing (apneas) or shallow breathing (hypopneas).
These interruptions can cause fragmented sleep, leading to daytime fatigue, cognitive impairments, and other health issues. Addressing mild OSA early is important, as it can progress to more severe forms if left untreated. OSA severity is measured using the Apnea-Hypopnea Index (AHI), which counts the number of apneas and hypopneas per hour of sleep. Estimates suggest that mild OSA, defined by an AHI of 5-14.9 events per hour, affects about 9-38% of adults with and increased prevalence in men and older adults. The Oxygen Desaturation Index (ODI) has been shown to be an alternative measure for OSA severity since AHI and ODI are heavily correlated and ODI is a valid predictor of OSA severity.
There are many treatment options available for patients with various severities of OSA. The gold standard for treating moderate or severe sleep apnea is Continuous Positive Airway Pressure (CPAP). CPAP therapy involves wearing a mask that provides a continuous flow of air to keep the airway open during sleep. However, some patients find CPAP uncomfortable or inconvenient, leading to patient compliance issues. Another option for patients with moderate or severe OSA is the use of intraoral devices. These devices reposition the lower jaw and tongue to keep the airway open. They require custom fitting by a dentist trained in sleep medicine. Access to these specialists, as well as concerns about discomfort and impact on teeth, can also limit their use as well as patient compliance.
For patients with mild OSA, positional therapy is a promising alternative. Positional therapy aims to prevent patients from sleeping in positions that exacerbate OSA, such as lying on their back (supine position), which has been demonstrated to worsen airway obstruction. Effective positional therapy should encourage side sleeping (lateral positioning) or elevating the head and shoulders, which can help reduce apneic events.
The American Academy of Sleep Medicine (AASM) "Practice Parameters for Medical Therapy of OSA" recommends positional therapy as an effective, non-invasive secondary treatment for mild OSA, especially when used alongside primary treatments like CPAP (AASM Guideline 3.5). FDA-authorized devices used for positional therapy include specialized pillows, belts, and electronic trainers that help maintain a side-sleeping or elevated position throughout the night. These devices are attractive solutions for patients for which CPAP may not be a practical first-line solution, such as patients with mild OSA.
The device that is the subject of this submission, the MedCline Sleep System, is a pillow-based positional therapy device based on the sleep positioning principles described above.
- Conditions
- Mild Obstructive Sleep Apnea
- Being tested
- MedCline Sleep System
- Keywords
- mild OSA, positional therapy, supine avoidance, lateral sleeping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedCline Sleep SystemDevice
The MedCline Sleep System is an at-home positional therapy device to be placed on a bed surface.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Device | Experimental | This study will compare outcome measures for participants using their own pillow(s) vs. using the MedCline Sleep System. Receives: Device: MedCline Sleep System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of AHI on Apnea-Hypopnea Index scale
Change in apneas per hour as measured by PSG (in-lab)
Measured: Night 1 to Night 8
Reduction of ODI on Oxygen Desaturation Index Scale
Change in oxygen desaturation per hour via PSG (in-lab)
Measured: Night 1 to Night 8
Secondary outcomes (2)
Reduction in Snoring
Change in snoring during night
Measured: Night 1 to Night 8
Reduction in Time Spent Supine
Reduction in Time Spent Supine
Measured: Night 1 to Night 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mild Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, prospective, single-arm, within-subject study to evaluate the safety and effectiveness of the MedCline Sleep System.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amenity Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Ojile, FCCP, D-ABSM, Principal investigator, Clayton Sleep Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492420
- Sponsor's protocol ID
- MSS001
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Morgenthaler T, Kramer M, Alessi C, Friedman L, Boehlecke B, Brown T, Coleman J, Kapur V, Lee-Chiong T, Owens J, Pancer J, Swick T; American Academy of Sleep Medicine. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An american academy of sleep medicine report. Sleep. 2006 Nov;29(11):1415-9.
PubMed 17162987van der Hoek LH, Rosenmoller BRAM, van de Rijt LJM, de Vries R, Aarab G, Lobbezoo F. Factors associated with treatment adherence to mandibular advancement devices: a scoping review. Sleep Breath. 2023 Dec;27(6):2527-2544. doi: 10.1007/s11325-023-02862-9. Epub 2023 Jun 29.
PubMed 37386300Varghese L, Rebekah G, N P, Oliver A, Kurien R. Oxygen desaturation index as alternative parameter in screening patients with severe obstructive sleep apnea. Sleep Sci. 2022 Jan-Mar;15(Spec 1):224-228. doi: 10.5935/1984-0063.20200119.
PubMed 35273770Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
PubMed 23589584
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
- ClinicalTrials.gov ID
- NCT07492420
- Acronym / sponsor ID
- MSS001
- Conditions
- Mild Obstructive Sleep Apnea
- Keywords
- mild OSA, positional therapy, supine avoidance, lateral sleeping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Amenity Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.
Detailed description
OSA is a common sleep disorder characterized by partial or complete obstruction of the upper airway during sleep that leads to intermittent pauses in breathing (apneas) or shallow breathing (hypopneas).
These interruptions can cause fragmented sleep, leading to daytime fatigue, cognitive impairments, and other health issues. Addressing mild OSA early is important, as it can progress to more severe forms if left untreated. OSA severity is measured using the Apnea-Hypopnea Index (AHI), which counts the number of apneas and hypopneas per hour of sleep. Estimates suggest that mild OSA, defined by an AHI of 5-14.9 events per hour, affects about 9-38% of adults with and increased prevalence in men and older adults. The Oxygen Desaturation Index (ODI) has been shown to be an alternative measure for OSA severity since AHI and ODI are heavily correlated and ODI is a valid predictor of OSA severity.
There are many treatment options available for patients with various severities of OSA. The gold standard for treating moderate or severe sleep apnea is Continuous Positive Airway Pressure (CPAP). CPAP therapy involves wearing a mask that provides a continuous flow of air to keep the airway open during sleep. However, some patients find CPAP uncomfortable or inconvenient, leading to patient compliance issues. Another option for patients with moderate or severe OSA is the use of intraoral devices. These devices reposition the lower jaw and tongue to keep the airway open. They require custom fitting by a dentist trained in sleep medicine. Access to these specialists, as well as concerns about discomfort and impact on teeth, can also limit their use as well as patient compliance.
For patients with mild OSA, positional therapy is a promising alternative. Positional therapy aims to prevent patients from sleeping in positions that exacerbate OSA, such as lying on their back (supine position), which has been demonstrated to worsen airway obstruction. Effective positional therapy should encourage side sleeping (lateral positioning) or elevating the head and shoulders, which can help reduce apneic events.
The American Academy of Sleep Medicine (AASM) "Practice Parameters for Medical Therapy of OSA" recommends positional therapy as an effective, non-invasive secondary treatment for mild OSA, especially when used alongside primary treatments like CPAP (AASM Guideline 3.5). FDA-authorized devices used for positional therapy include specialized pillows, belts, and electronic trainers that help maintain a side-sleeping or elevated position throughout the night. These devices are attractive solutions for patients for which CPAP may not be a practical first-line solution, such as patients with mild OSA.
The device that is the subject of this submission, the MedCline Sleep System, is a pillow-based positional therapy device based on the sleep positioning principles described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, prospective, single-arm, within-subject study to evaluate the safety and effectiveness of the MedCline Sleep System.
| Arm | Type | Receives |
|---|---|---|
| Intervention Device | Experimental | Device: MedCline Sleep SystemThis study will compare outcome measures for participants using their own pillow(s) vs. using the MedCline Sleep System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis with mild obstructive sleep apnea (AHI 5-14.9)
- PSG or HST performed within last 24 months
- Individuals aged 18 or older
- Must routinely sleep on a standard mattress and must be able to accommodate the width of the MedCline Sleep System (30")
- Must be in overall good health, with no significant medical conditions that would interfere with the study procedures or the ability to sleep safely using the MedCline Sleep System
Key exclusion criteria (8 listed)
- Diagnosis of moderate to severe OSA (AHI >15) or central sleep apnea
- Has undergone surgical procedures for sleep apnea within the last six months
- Clinically significant cardiac or respiratory conditions that may interfere with the study intervention or outcomes.
- Chronic pain or musculoskeletal disorders, e.g., spinal deformities, scoliosis, kyphosis, back injuries, spinal compressions, or injuries that may affect their ability to sleep comfortably in a lateral position
- Pregnant or planning to become pregnant during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedCline Sleep SystemThe MedCline Sleep System is an at-home positional therapy device to be placed on a bed surface. | Device | Intervention Device |
Primary outcome
Reduction of AHI on Apnea-Hypopnea Index scale
Time frame: Night 1 to Night 8
Change in apneas per hour as measured by PSG (in-lab)
Reduction of ODI on Oxygen Desaturation Index Scale
Time frame: Night 1 to Night 8
Change in oxygen desaturation per hour via PSG (in-lab)
2 secondary outcomes
Reduction in Snoring
Time frame: Night 1 to Night 8
Reduction in Time Spent Supine
Time frame: Night 1 to Night 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 17162987Morgenthaler T, Kramer M, Alessi C, Friedman L, Boehlecke B, Brown T, Coleman J, Kapur V, Lee-Chiong T, Owens J, Pancer J, Swick T; American Academy of Sleep Medicine. Practice parameters for the psychological and behavioral treatment of insomnia: an update. An american academy of sleep medicine report. Sleep. 2006 Nov;29(11):1415-9.
- Background: PubMed 37386300van der Hoek LH, Rosenmoller BRAM, van de Rijt LJM, de Vries R, Aarab G, Lobbezoo F. Factors associated with treatment adherence to mandibular advancement devices: a scoping review. Sleep Breath. 2023 Dec;27(6):2527-2544. doi: 10.1007/s11325-023-02862-9. Epub 2023 Jun 29.
- Background: PubMed 35273770Varghese L, Rebekah G, N P, Oliver A, Kurien R. Oxygen desaturation index as alternative parameter in screening patients with severe obstructive sleep apnea. Sleep Sci. 2022 Jan-Mar;15(Spec 1):224-228. doi: 10.5935/1984-0063.20200119.
- Background: PubMed 23589584Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
- Individual participant dataSharing planned: No
Related trials for Mild Obstructive Sleep Apnea
RecruitingPhase 1
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Sleep Apnea, Obstructive
Recruiting
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
Obstructive Sleep Apnea, Alzheimer Disease
RecruitingPhase 2
Study to Examine the Effect of Silicone Mouth Tape on Snoring and Mild Sleep Apnea.
Mild Obstructive Sleep Apnea, Snoring
Not yet recruiting
Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).
Snoring, OSA - Obstructive Sleep Apnea
Recruiting
OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?
Apnea, Obstructive Sleep, Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Ojile, FCCP, D-ABSM principal investigator
Clayton Sleep Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedCline Sleep System in people with Mild Obstructive Sleep Apnea, run by Amenity Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of AHI on Apnea-Hypopnea Index scale (time frame: Night 1 to Night 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07492420, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.