CONSENT  

Your participation in this study will last up to fourteen days. You will be expected to charge the study device(s) at your place of residence following wear. We will also validate that your cell phone is active, and the number you have provided is correct. You will identify the time of day you would like to receive your daily questionnaire via text message. 

If you consent to begin the study, then the following will happen:

STUDY TREATMENT 

You will be fitted for the ATTN201 device by a trained technician. You will be asked to wear the study device(s) daily OR nightly. The ATTN201 device will record your head movements and the electrical activity in your brain using small, metal discs (electrodes). If worn overnight, the ATTN201 device will be tethered via 6ft+ flexible tubing to a small plastic and metal box (a mock power control unit) which can be placed on your nightstand or the floor beside your bed. 

You may also be asked to wear or alternate ATTN201 device wear with a Dreem 3 band for collecting EEG data and/or a wrist-worn sensor for tracking your movement. You will complete a daily study questionnaire about your experience with the study device overnight. 

Some participants may be asked to undergo an overnight PSG at a sleep clinic to measure EEG, movements, breathing and heart rate. You may have to wear electrodes similar to those in the study device. 

AFTER STUDY TREATMENT

Because this is a research study, the study device will be given to you only during this study and will not be available after the study is over.

EXPECTATIONS 

If you decide to participate in the study, you will be expected to:

1. Own a cell phone with active data plan for the duration of the study

2. Attend a fitting of the study device by a trained technician including the application of foam padding of various sizes

3. Wear the agreed upon study device(s) to include ATTN201, Dreem 3 or wrist-worn accelerometer for an agreed upon number of days OR nights not exceeding two weeks (14 days)

4. Charge the study device(s) daily as needed

5. Replace or re-wet electrodes for the ATTN201 device as needed

6. Complete a daily study questionnaire 

7. Undergo in-laboratory PSG when participant location allows

8. Return the study device at the completion of the study

RISKS, SIDE EFFECTS, AND/OR DISCOMFORTS 

There are no known physical risks associated with questionnaire assessment procedures. However, if the questions are upsetting to you in any way, you do not have to answer them.

EEG data collection via ATTN201 or Dreem 3 may induce discomfort from wear and increased awakenings throughout the night. The ATTN201 headband utilizes medical grade electrode pads which may cause skin irritation in some participants. The flexible tubing connecting the ATTN201 headset to the mock control unit could pose a tangling or choking hazard. You will be shown how to position the tubing properly towards the head of the bed at night to mitigate tangling and/or choking risks. You can remove study devices or discontinue participation at any time. 

Accelerometry data collection may induce discomfort from study device wear. You can remove study devices or discontinue participation at any time.

Some participants will be asked to undergo polysomnography (PSG) in a sleep laboratory. PSG is a noninvasive, painless test. The most common side effect is skin irritation caused by the adhesive used to attach test sensors. PSG’s will be conducted under supervision of an experienced board certified polysomnographer.

NEW FINDINGS 

Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.

BENEFITS

This study is for research purposes only. There is no direct benefit to you from your participation in the study. Information learned from the study will inform the design of a device for improving sleep and may help other people in the future. 

The study investigator can provide your EEG, accelerometry or PSG data if interested; however, no medical advice will be provided. 

COMPENSATION FOR PARTICIPATION 

In exchange for participation in the study, participants will have access to their own data for informational purposes. While we may help participants interpret or understand scaling of data provided to them, study staff will not provide medical advice or diagnosis to participants. 

No financial compensation will be provided for participation.

CONFIDENTIALITY  

Research material obtained may consist of study questionnaires, EEG data collection, accelerometry data collection, and PSG data collection (if applicable). Data will be obtained for research purposes only and specific individual results will not be provided to participants or their families, except as otherwise described above. EEG, accelerometry and PSG data collected will be anonymized and encrypted when sharing electronically for analysis.

Records of your participation in this study will be held confidential except when sharing the information is required by law or as described in this informed consent. The study investigator, the sponsor or persons working on behalf of the sponsor, and under certain circumstances, the United States Food and Drug Administration (FDA) and the Institutional Review Board (IRB) will be able to inspect and copy confidential study-related records which identify you by name. This means that absolute confidentiality cannot be guaranteed. If the results of this study are published or presented at meetings, you will not be identified.

IF YOU ARE INJURED 

If you become ill or are injured while you are in the study, get the medical care that you need right away. You should inform the healthcare professional treating you that you are participating in this study. If you tell the study staff that you think you have been injured then they will help you get the care you need. 

If you are injured as a result of using the study device(s) for the purpose of this study, the sponsor will pay for those medical expenses necessary to treat your injury that are not covered by your medical insurance or any other third-party coverage. By signing and dating this document, you will not lose any of your legal rights or release anyone involved in the research from responsibility for mistakes.

To pay medical expenses, the sponsor will need to know some information about you like your name, date of birth, and Medicare Beneficiary Identifier (MBI). This is because the sponsor has to check to see if you receive Medicare and if you do, report the payment it makes to Medicare.

COSTS 

There will be no charge to you for your participation in this study. The study-related materials and study visits will be provided at no charge to you or your insurance company.

FINANCIAL DISCLOSURE

An investigator on this study has an ownership interest in Attune Neurosciences, Inc. the company sponsoring this research study. As a result, the investigator may benefit financially from a successful study. Please speak with the study investigator if you have questions about this. 

FUTURE RESEARCH STUDIES 

Your private information collected during this study will not be used or distributed for future research studies.

WHOM TO CONTACT ABOUT THIS STUDY

During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:

• Whom to contact in the case of a research-related injury or illness;

• Payment or compensation for being in the study, if any;

• Your responsibilities as a research participant;

• Eligibility to participate in the study;

• The study investigator’s or study site’s decision to exclude you from participation;

• Results of tests and/or procedures;

Please contact the study investigator at the telephone number listed on the first page of this consent document.

If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study. 

An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, contact:

• By mail:

Study Subject Adviser

Advarra IRB

6100 Merriweather Dr., Suite 600

Columbia, MD 21044

• or call toll free:    877-992-4724

• or by email:          adviser@advarra.com

Please reference the following number when contacting the Study Subject Adviser: Pro00066769.

VOLUNTARY PARTICIPATION / WITHDRAWAL 

Your decision to participate in this study is voluntary. You may choose to not participate or you may withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care. However, please note that the FDA requires that any information collected up to the point of your withdrawal cannot be removed from the study.

The study investigator or the sponsor can stop your participation at any time without your consent for the following reasons:

• If it appears to be medically harmful to you;

• If you fail to follow directions for participating in the study;

• If it is discovered that you do not meet the study requirements;

• If the study is canceled; or 

• For administrative reasons.

If you are an employee or relative of an employee of this research center, you are under no obligation to participate in this study.  You/your family member may withdraw from the study at any time and for any reason, and neither your/your family member’s decision to participate in the study, nor any decision on your/their part to withdraw, will have any effect on your/your family member’s performance appraisal or employment at this clinical research center.  You/your family member may refuse to participate or you/your family member may withdraw from the study at any time without penalty or anyone blaming you. 

ALTERNATIVES TO PARTICIPATION 

This research study is for research purposes only. The only alternative is to not participate in this study.