The Daybreak Patient Care Guarantee

Updated January 17, 2025

At Daybreak, we specialize in creating oral devices designed to help patients with obstructive sleep apnea (OSA) breathe freely and sleep comfortably by keeping their airways open. Oral appliances have long been a trusted and effective treatment for OSA, and we are proud to make these clinically prescribed, industry-gold-standard devices more accessible by delivering them directly to patients’ homes.

Here’s Why We’re Confident

Oral appliance devices like the Daybreak Device consistently earn praise from sleep specialists, including pulmonologists, ENT doctors, and physicians. When given a choice between an oral appliance and a CPAP machine, many patients prefer the simplicity and comfort of our device, making it a true “Patient’s Choice.”

A recent systematic review published on February 16, 2024, by the American Academy of Otolaryngology-Head and Neck Surgery Foundation analyzed 42 studies involving 2,265 patients. The findings confirmed that oral appliances, such as mandibular advancement devices (MADs) like the Daybreak Device*, are the recommended first-line treatment for mild-to-moderate obstructive sleep apnea-hypopnea (OSA-H) and have even shown to be effective in severe cases. Read the full study here.

The Daybreak Patient Care Guarantee

We are confident that the Daybreak Device can be a life-changing solution for most patients with obstructive sleep apnea. To ensure your confidence in choosing Daybreak, we proudly offer the Daybreak Patient Care Guarantee as described below (the “Patient Care Guarantee”).

Our Commitment to You

Suppose a physician diagnoses you with clinical obstructive sleep apnea and you pursue treatment with the Daybreak Device in accordance with the Patient Care Guarantee terms herein. In that case, we will provide you with our money-back guarantee described below if you do not receive a 50% or greater reduction outcome in your measured AHI4 from your baseline diagnosis or an AHI4 score reduced to below 5 (“Patient Care Outcome”).

If this Patient Care Outcome is not achieved within the first 90 days of receiving your customized Daybreak Device, you have followed and completed the Clinical Treatment Plan during this period, and you are in compliance with the terms required herein, we will fully refund the medical device cost** of your initial Daybreak Device purchase. Simply reach out to our support team to make this request.

How to Qualify for the Patient Care Guarantee

To qualify, patients must follow, complete, and actively engage with the clinical treatment plan as directed by the prescribing clinician and Daybreak supporting personnel along with Daybreak Device care instructions (collectively, the “Clinical Treatment Plan”) by complying with the each of the foregoing and the following:

• Timely responding to check-in questions to help us monitor progress.
• Wearing the Daybreak Device consistently each night while sleeping to support the lower jaw in a forward position in accordance with the Clinical Treatment Plan.
• Following all device adjustment suggestions provided by our team.
• Following best practice methods for properly cleaning, storing and using the Daybreak Device, including consistent use of an approved cleaning option such as the Ultrasonic Cleaner available here: https://www.thedaybreak.com/products/ultrasonic-cleaner.
• Completing any at-home sleep tests as requested or required under the Clinical Treatment Plan, including follow-up sleep tests to measure AHI4 throughout the initial 90-day period.
• Ensuring all check-ins and requests are completed within 2 weeks of receiving them.

To qualify, patients must also be in compliance with the eligibility requirements and other terms of the “Daybreak Consent” (as set forth at the following link and incorporated herein by this reference: https://www.thedaybreak.com/legal/consent) and the terms of the “Patient Agreement” (as set forth at the following link and incorporated herein by this reference: https://www.thedaybreak.com/legal/agreement).

If the Patient Care Outcome is not met, the Clinical Treatment Plan has been followed and completed, and you are in compliance with the terms required herein, then the Daybreak Device must be returned to us at our designated return address for proper disposal before a refund may be issued.

Important Notes and Limitations

What’s Covered: A refund of the medical device cost** of your initial Daybreak Device purchase in the event that the use of the Daybreak Device in accordance with the completed Clinical Treatment Plan and terms herein does not result in the Patient Care Outcome within the first 90 days of receiving your customized Daybreak Device.

What’s Not Covered: Notwithstanding the foregoing, in the event that the Daybreak Device is damaged by carelessness (e.g., such as destruction by pets or improper storage), misuse, negligence or willful damage, there is unreasonable wear and tear, tampering by an unqualified person, use contrary to the Daybreak Device care instructions and Clinical Treatment Plan or the Daybreak Device has been purchased from an unauthorized seller, then such Daybreak Device will not be eligible for a refund under the terms of this Patient Care Guarantee. We are not responsible for lost, stolen, or damaged devices. The Patient Care Guarantee applies to the initial Daybreak Device purchase only and does not include any back-up or replacement Daybreak Device purchases.

Side Effects: While rare, some patients may experience minor side effects such as jaw soreness or tooth discomfort. These typically resolve with adjustments. Please review the Daybreak Consent for other potential side effects. If you have concerns, consult with your care provider or contact our support team for assistance.

Resolved Dental Issues: You acknowledge and agree that you have been advised to first seek clinical treatment to fully and completely resolve any existing dental issues prior to proceeding with the use of the Daybreak Device. You acknowledge and agree that you have resolved all dental issues prior to your use of the Daybreak Device, no dental issues exist during the period of your use of the Daybreak Device and that you do not have any of the dental conditions or situations listed under the “Eligibility for Daybreak MAD (Daybreak Device)” provision of the Daybreak Consent.

Non-Compliance: If you fail to follow the Clinical Treatment Plan or other instructions of your healthcare provider or Daybreak (Sleepcare LLC) regarding the use and care of the Daybreak Device or fail to comply with the foregoing terms of this Patient Care Guarantee, this Patient Care Guarantee policy may be voided.

At Daybreak, we stand by the quality and effectiveness of our devices and are committed to helping you achieve better sleep and health. With the Daybreak Patient Care Guarantee, you can begin your journey to restful nights with peace of mind.

Please note that the terms of this Patient Care Guarantee may be revised and updated on this webpage from time to time by Daybreak in its discretion, and the then-current terms of the Patient Care Guarantee that are effective as of the date of submission (if any) will apply for a qualifying request for refund under the Patient Care Guarantee.

*The Daybreak Device is currently FDA-cleared to reduce snoring and mild-to-moderate obstructive sleep apnea in patients 22 years of age or older.

**While the medical device cost of your Daybreak Device purchase is refundable in accordance with the terms of this Patient Care Guarantee, please note that the amounts of the dental services fee and medical services fee charged by the applicable dental services and medical services providers for your case are required services fees and are therefore nonrefundable.