Daybreak Consent

Updated January 16, 2024

Informed Consent to Use of Home Sleep Testing, Daybreak Device, Morning Repositioner, and Telehealth Services

I understand and acknowledge that Sleepcare Now LLC d/b/a Daybreak employees and contractors, and the virtual medical and dental professionals responsible for my care (“Virtual Medical Professionals” and “Virtual Dental Professionals”) (collectively, “Daybreak”) during the course of my participation in the Daybreak program (“Daybreak Treatment Program”) may provide me with certain products and services, leveraging technology tools, including asynchronous and/or synchronous telehealth technologies (“Telehealth Technology”).

The purpose of this consent document (this “Consent”) is to provide you with highly important information about the products offered in connection with the Daybreak Treatment Program and the use of Telehealth Technology by Virtual Medical and Dental Professionals to determine whether the Daybreak Treatment Program is appropriate for you and, if so, provide you with treatment. This information is intended to enable you to make an informed decision about whether the Daybreak Treatment Program and the use of Telehealth Technology is appropriate for your condition and needs, and fully understand the benefits and risks associated with the Daybreak Treatment Program and Telehealth Technology.

You have the right to withdraw this Consent at any time by sending written notice including your name and address to support@thedaybreak.com. You understand and agree that your withdrawal will be effective upon Daybreak’s receipt of this written notice, except that your withdrawal will not have any effect on any action taken by Daybreakin reliance on this Consent before the withdrawal notice was received. You acknowledge and agree, however, that withdrawal of this Consent may result in the termination of your access to certain services from Daybreak.

About Daybreak and OSA Treatment

How Daybreak Helps You

Daybreak makes sleep apnea diagnosis and treatment accessible and convenient. We connect you with experienced medical professionals who diagnose and treat obstructive sleep apnea (OSA) via telehealth . Daybreak offers custom mandibular advancement devices (“MADs”) made from biocompatible materials that are designed to gently reposition your lower jaw and improve your airway during sleep. This process typically starts with an at-home sleep test, which is then reviewed by a medical professional. If you are diagnosed with OSA and decide to proceed with treatment, you will receive an impression kit to take your own dental impressions at home. Based on these impressions, we create and ship you a custom MAD. Below, you will find valuable information that may help you decide whether Daybreak's sleep apnea treatment is the right fit for you, including benefits, potential difficulties, and risks associated with the treatment. Should you have any questions or concerns, feel free to reach out to Daybreak's customer care team. We are here to help you reach your goal of restful sleep.

Benefits

Daybreak's custom MADs are designed to be discreet, comfortable, and easy to wear.The custom-fit ensures that the device stays in place throughout the night, allowing you to sleep in any position. Plus, our treatment allows you to maintain your regular oral hygiene routine. Brushing, flossing, and eating proceed as normal—no disruptions or difficulties involved.You repeat your home sleep test and work with our care team to ensure that your device is working to treat your sleep apnea appropriately.

Importance of Treating OSA

I understand that OSA is a serious and potentially life-threatening medical condition.I recognize that neglecting to treat OSA may elevate the risk of developing hypertension, angina, and may increase the likelihood of serious physical issues including, but not limited to: diabetes, GERD, dementia, sexual dysfunction, mood disorders, depression, insomnia, increased motor vehicle accidents, hypertension (high blood pressure), excessive daytime sleepiness, fatal outcomes from stroke, myocardial infarction (heart attack), and cardiac arrhythmia. I hereby grant permission for my diagnostic and treatment records to be utilized for research, educational, or publication purposes in professional journals.

OSA is an Alternative Treatment

I have elected to have a custom oral appliance made to be worn during sleep, to help improve the symptoms of OSA. I understand that this is an alternative treatment (of OSA) to other treatments such as CPAP and oral/pharyngeal/nasal surgeries, and I understand that this device is designed to sustain an unobstructed airway to facilitate and quiet breathing while asleep. While this device has demonstrated efficacy for many individuals, it is recognized that due to physiological, anatomical variations, and individual adaptation, there can be no guarantee that it will be successful in treating my sleep apnea. I understand that successful treatment requires compliance with treatment and my following of any guidelines and instructions.

No Guaranteed Improvement

Daybreak cannot guarantee the success of any type of therapy and cannot ensure that any person will comply with treatment. I acknowledge that using an MAD might not bring about the desired improvement in my OSA and continuous evaluation with a healthcare professional is recommended. Seeking in-person care with a physician or sleep specialist is always encouraged for comprehensive management.

Daybreak Treatment Program Eligibility

Eligibility for At-Home Sleep Testing

You must NOT have any of the following conditions or situations to be eligible for at-home sleep testing:

Serious heart or lung disease, including but not limited to pulmonary hypertension, moderate to severe pulmonary disease (e.g., COPD), congestive heart failure, or uncontrolled cardiac arrhythmia
A history of prior stroke or any condition requiring a pacemaker
Neuromuscular disease (e.g., Parkinson’s disease, spina bifida, myotonic dystrophy, amyotrophic lateral sclerosis)
Epilepsy
Chronic opioid medication use
Super obesity (BMI greater than 40)
Periodic limb movement disorder or restless leg syndrome
Sleep disorders that are unusual or atypical, including but not limited to parasomnias (e.g., nocturnal seizures, psychogenic dissociative states, REM sleep behavior disorder), severe insomnia, narcolepsy, central sleep apnea, or complex sleep apnea
Oxygen dependence
Younger than 22 years of age

Eligibility for Daybreak MAD (Daybreak Device)

While Daybreak's MAD offer a convenient and effective treatment for many people with OSA, they are not suitable for everyone.

By proceeding with your request for a custom MAD through Daybreak, you affirm that you meet specific dental health criteria essential for the effective and safe use of the appliance. Specifically, you confirm that you do not have any of the following dental conditions or situations:

Loose teeth or missing a significant number of missing teeth
Have at least 2 molars on each side of your upper jaw and 2 molars on each side of your lower jaw
Severe gum disease, periodontal disease, or any current mouth infections or problems
Recent dental implants or oral surgery within the last year, excluding crowns, caps, or fillings
TMJ (jaw joint) issues or experience pain when opening or closing your mouth
Temporary or unfinished dental work such as crowns, caps, bridges, or fillings
Current orthodontic treatment including braces, Invisalign, or clear aligners
Severe open bites, severe overjet, severe overbite, tooth malocclusion requiring surgical correction, mixed dentition (both infant and adult teeth), dental prosthetics or dental implants, active periodontal disease, active tooth decay or dental caries, permanent retainers, mental illness or PETG material allergy.

Impression Kit

In rare instances, some people may be allergic to the materials used or other included materials. If you happen to be one of them, stop using immediately and contact a health care professional immediately. Sleep appliances and repositioners can be accidentally swallowed or aspirated and may be harmful.

Pregnancy

For women who are or may become pregnant: I agree that, although I may start or continue treatment during pregnancy, in order to do so, I will receive authorization from my treating physician prior to starting or continuing Daybreak sleep apnea treatment. While I do not have to provide this authorization to Daybreak, by agreeing to this section, I agree that it is my obligation to communicate with my doctor prior to starting or continuing the treatment process during pregnancy.

By signing this Informed Consent, you affirm your eligibility for receiving a custom MAD and confirm your understanding that failing to meet these conditions may compromise the efficacy of the treatment and potentially worsen your dental health.The Daybreak Treatment Program is not intended as a replacement for regular medical and dental examinations.

Daybreak Treatment Program Procedure, Diagnosis and Results

Procedure

Home Sleep Test Kit: Upon receiving your consent, we will send you an at-home sleep test kit.
Test Review: A Virtual Medical and Dental Professional will review the results and determine appropriate treatment.
Diagnosis: If diagnosed with OSA, you will be eligible for further treatment, which may include an MAD.

Duration and Results

MAD are alternative treatment for OSA.They are intended to be worn during sleep and are not considered a cure for OSA.The morning repositioner is recommended to be worn every morning for at least 5-10 minutes to help restore your natural bite and minimize side effects.Devices and their components (bands) will wear out over time and require replacement.Replacement may or may not be covered by your insurance.

Potential Adverse Effects, Contacting Daybreak

Potential Adverse Effects of Oral Appliances

I acknowledge that oral appliances can potentially have several side effects, some of which might not be noticeable for an extended period.These side effects can include (but are not limited to): pain and discomfort in the teeth, jaws, and surrounding structures when wearing the device, dry mouth, increased salivation, increased risk of dental decay/cavities, periodontal disease, dry mouth, the loosening or loss of ill-fitting crowns and fillings, the loosening of teeth, tooth loss, gum or softirritation, teeth or muscle aches, tooth movement, bite or occlusion changes that could be permanent, jaw or joint pain, and may cause or exacerbate temporomandibular joint dysfunction. In addition, in some circumstances discoloration or white spots may occur; small cavities may increase in size, causing sensitivity and in some cases pain or tooth fracture; gum/gingival inflammation may increase causing soreness and or bleeding. If underlying periodontal conditions go unchecked, they may become more advanced leading to tooth loss. You may have to discontinue MAD treatment. All of these symptoms will require you to seek care from a dentist of your choice. In a minority of patients utilizing an oral appliance, the number of apnea and hypopnea events may increase. A post-placement polysomnogram is recommended. I acknowledge that it is possible for some customers to become allergic to the materials used to create the Daybreak Device, or morning repositioner aligner. If you experience a reaction, please discontinue use and inform us and your primary care provider immediately.The devices and their associated components may break, be swallowed, or inhaled.

When to Contact Daybreak

I understand that although the oral appliance is not designed to alter my jaws or teeth, should I or my dentist observe such changes, I will promptly notify Daybreak. Furthermore, should I experience any dental, jaw, or muscle discomfort, barring mild, short-term discomfort in the mornings, I will notify Daybreak. I am aware that there may be unforeseen risks or complications that have not been discussed, and no assurances or pledges have been made to me regarding the treatment outcome.

By signing this Consent, you hereby represent that you have fully read and understand the terms, and you fully agree to and accept all of the terms set forth herein.