SnoreX LLC (DBA Soundly) is conducting a research study to evaluate efficacy of myofunctional therapy in reducing snoring and sleep apnea. Participation is completely voluntary. <br> We are asking you to consider being part of this study because you have self-reported issues with snoring and/or sleep apnea. By checking all of these boxes you are agreeing to participate in this study, which will allow the data you provide in this app and as part of this study to be used for research purposes. Your data will be anonymized in any research publications. 

 

All participants are asked to follow the text and video instructions in this app that will guide them through 5 to 10 minutes of myofunctional therapy each day for up to 12 weeks.

 

 The risks or discomforts from participating in this study are: sore throat or facial/upper airway muscles from exercise. Severe soreness or discomfort is rare and the participant should stop the exercises if they experience severe soreness or discomfort. There is also the risk of loss of confidentiality of voluntarily provided medical and personal information as part of this study. Soundly has taken steps to secure, encrypt, and anonymize data. There are no guaranteed benefits to the study participants, however, they may experience reduced snoring and/or sleep apnea. An alternative to participating in this research are over the counter snore reducing solutions and seeking medical advice from your doctor. This study is not able to diagnose or treat sleep apnea but measures of sleep apnea may be taken and reductions may be noticed along with reductions in snoring. Treatment of sleep apnea should be done through your medical provider. There will be no cost to you and you will not be paid for participating in this study. 

 

If you do not  take part in the study or  decide to discontinue your participation, there will be no penalty to you. If you don’t take part, it won’t affect the care you receive from your doctor or other benefits to which you are entitled. If those conducting the study think it’s not in your best interest to continue or decide to stop the study, we will end your participation. 

 

 To do this research, we need to collect health information that identifies you. We may collect the results of questionnaires, interviews, in-app statistics (like amount of time using the app), and results from at home sleep studies. For you to be in this research, we will need your permission to collect and share this information.

 

All study and health information collected by the study team will be kept confidential. We are asking for your permission to use and/or share information that we collect during this research, such as name, age, sex, email, sleep apnea diagnosis, treatments used to date, time spent using the app, completion of exercises, self reported fatigue after the exercises, sleep quality questionnaire, and bed partner questionnaires. The information will be shared with the study sponsor and people or organizations that oversee research.  Some of the people or organizations that oversee research may not be subject to privacy laws, which means the information may no longer be covered by federal privacy laws.

 

 If you do not check all of these boxes you do not agree to allow your data to be used as part of scientific research that may benefit others. If you do not participate you may still use the Soundly app. Information you provide will be stored on encrypted servers to allow the app to operate but will not be used in research.

 

 Once you provide permission, it will not expire. But, you can withdraw from the study or cancel your permission for us to use your information at any time by writing to the researcher at admin@soundlyapp.com. If you decide you don’t want your information used, or if you have any questions or complaints, you may contact a person not on the research team at the Biomedical Research Alliance of New York Institutional Review Board at (516) 318-6877 or at www.branyirb.com/concerns-about-research. Information that was already collected may still be used and given to others.

 

Study-related costs associated with your being in this study will be paid by the sponsor, SnoreX LLC. The information collected, with or without identifiers, may be used for commercial profit and you will not share in this profit.

 

I consent and am willing to participate in the Soundly Research Study. Soundly Research Study: www.soundlyapp.com/consent