A Doctor's Comments

October 6, 2017

I, Dr. Steven J. Scheer, graduated from the Northwestern University Feinberg School of Medicine in 1974 and have been practicing medicine for the past 43 years. I have been practicing sleep medicine since 1999 and have made it the exclusive focus of my practice since 2006.

I am receiving no compensation for this declaration.

During my practice I have found that patient compliance in Continuous Positive Airway Pressure and other forms of airway pressure therapy (collectively CPAP) has been a troublesome issue. Discomfort caused by the feel of the CPAP mask against the face, the sense of being tethered, and the sound and feel of air leaks can all lead to noncompliance with therapy. Sadly, this often causes a downward spiral that can lead to patient mortality. Accordingly, any innovation that leads to improved patient compliance will save lives.

Air leaks, between mask material and a patient’s face, are a cause for patient noncompliance that is particularly hard to address. The high-pitched whistle of many air leaks is often intolerable to the patient or his sleep partner or both persons. Air leaks may also produce a repeated sound like air being let out of a balloon, which is also frequently intolerable. The jet of air from a leak may be directed toward one of the patient’s eyes, waking him up. Also, the patient’s sleep partner may find herself awakened by a sudden jet of air, as the patient shifts about during sleep. An air leak may be so pronounced that it attracts the household cat to the bed, to enjoy the cooling air stream. (In this declaration I use the male pronoun for the mask wearer and the female pronoun for the sleep partner, to avoid wordiness.)

Contact dermatitis, the persistent pressure contact between mask material and a patient’s face, has presented another troublesome problem for mask wearers. Sadly, an effort to stop or prevent a leak by tightening the straps holding the mask to the patient’s face increase the chance of contact dermatitis developing. Even in the absence of contact dermatitis, patient discomfort caused by the pressure against the patient’s face may cause therapy noncompliance.

Many patients have felt trapped between the need to prevent leaks, and the need for comfort while trying to sleep. Increasing patient compliance by addressing the problems of air leaks, contact dermatitis and the discomfort of mask material pressed against the patient’s face, have constituted a need in the industry since the inception of CPAP therapy for obstructive sleep apnea in the early 1980’s. I have a personal awareness of this fact through my work and through my many contacts with other professionals in the field, and familiarity with the literature. The introduction of mask liners, and the introduction of improved masks, before the CPAP Comfort Cover patent application was filed, have represented an effort on the part of others to solve this problem. Although this effort has yielded benefits, it has failed to fully solve this long-felt need.

Previous mask liners failed to fully address the long-felt need in the industry for a mask liner that would increase patient compliance by staying in position through the sleep period, preventing air leaks, preventing contact dermatitis and enhancing wearer comfort, while having consistently good ease-of-use across the full spectrum of patients. CPAP Comfort Covers solve this long-felt need because they provide the above-listed benefits to the full spectrum of patients, by requiring virtually no manual dexterity or attentiveness to attach to a CPAP mask, due to their elastic retention. They can also be removed, laundered, and replaced with little effort and little apparent diminution of effectiveness.

All statements made of my own knowledge are true, and all statements made on information and belief are believed to be true.

Dr. Steven J Scheer

Optimal Sleep Health    Sarasota, Florida

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