Project 68 Consent
Contact: info@dusq.com
Please read this Consent Form ("Consent Form") in full before submitting the Project 68 application form. By submitting the application form in which this Consent Form is presented, Participant agrees to the terms set out in this Consent Form. Direct any questions to info@dusq.com prior to submission.
Project 68 (the "Study") is a four (4) week prospective observational cohort study sponsored and conducted by Ezymind Nexus, Inc., a Delaware corporation ("Sponsor", "DUSQ", "we", "us"). The Study enrolls sixty-eight (68) adult participants ("Participants"), each of whom shall wear the DUSQ device, a behind-the-ear adhesive patch that delivers vestibular nerve stimulation during sleep (the "Device"), nightly for the four-week Study period.
The Study is designed to document changes in sleep-related parameters, subjective experience, and Device interaction over the Study period. Data collected through the Device, the DUSQ companion application, third-party wearable devices synchronised by the Participant, and Participant-reported responses will be aggregated and analysed for inclusion in a written report titled The 68 Project Report and any related Sponsor publications.
The Study is a prospective observational product evaluation. It is not a clinical trial and no medical claims are being made. Participants should consult a qualified healthcare professional for any health concerns.
Participation requires:
- Nightly wear of the Device for the entire four-week Study period.
- Completion of a brief weekly check-in questionnaire.
- Authorisation for the Sponsor to access and process the Participant's Device data, application data, and synchronised wearable sleep data.
By accepting this Consent Form, Participant authorises Sponsor to collect, process, and store the following categories of information:
- Personal information: name, email, phone, date of birth, gender, address, and time zone.
- Health information: sleep history, baseline sleep metrics, medical history relevant to eligibility, and contraindication screening responses.
- Device and application data: Device usage, session logs, sensor signals, and in-application interactions.
- Wearable and health-platform data: data synchronised from Participant's wearables and health platforms, including but not limited to Whoop, Oura, Apple Health, and Google Health, together with any other health-related data requested by Sponsor in connection with the Study, including sleep stages, heart rate, heart rate variability, body temperature, respiratory rate, and activity.
- Survey and qualitative responses: weekly check-ins, sleep diaries, written and verbal feedback.
- Communications: emails, messages, and any calls with the Sponsor that Participant agrees to record.
Sponsor uses the data described in Section 2 for the following purposes:
- Conducting Project 68 and documenting the complete four-week Participant experience with the Device.
- Preparing, publishing, and distributing The 68 Project Report and any related Sponsor publications.
- Improving the Device, the DUSQ application, and the Sponsor's internal algorithms.
Participant shall not be identified by name in any research publication.
Sponsor does not sell Participant's personal data. Sponsor may share the data described in Section 2 only:
- With service providers and consultants engaged by Sponsor to support the Study, under written confidentiality obligations.
- In aggregate or anonymised form, in reports and publications.
- Where required by law, regulation, court order, or to protect the safety of Participants or others.
Participant acknowledges that wearing the Device, like any wearable that contacts the skin and stimulates the nervous system, carries certain risks and discomforts. These include, without limitation:
- Skin reactions at the patch application site, including redness, itching, irritation, dryness, or contact dermatitis.
- Localised tingling, mild discomfort, or a pulling sensation while the Device is active.
- Transient changes in sleep architecture during the first nights of use as the body adjusts to a new stimulus.
- Discomfort on removal of the adhesive patch.
- Unknown or unforeseeable risks that may emerge during the Study.
Contraindications
Participant must not enrol in the Study if any of the following apply:
- Participant is under 18 years of age.
- Participant is pregnant, breastfeeding, or actively trying to conceive.
- Participant has an implanted electronic medical device, including a pacemaker, implantable cardioverter-defibrillator, deep brain stimulator, vagus nerve stimulator, or cochlear implant.
- Participant has a severe or unstable cardiac arrhythmia or active cardiovascular disease.
- Participant has had ear, head, or neck surgery within the past six (6) months.
- Participant has an active skin condition, wound, infection, or irritation at the intended patch site.
- Participant has severe untreated sleep-disordered breathing, except where Participant's treating physician has approved participation in writing.
- Participant's treating physician has advised against use of the Device.
For any medical condition, disorder, or diagnosis not listed above that may reasonably be affected by use of the Device or by participation in the Study, Participant shall obtain written approval from a treating physician before enrolling, and shall provide such approval to Sponsor on request.
Continuation of existing medications and devices
Participation in the Study does not require Participant to discontinue any medication, supplement, treatment, or wearable device that Participant is currently using. Participant shall not alter Participant's existing treatments solely for the purpose of the Study.
If Participant experiences any adverse effect during the Study, Participant shall discontinue use of the Device and contact Sponsor at info@dusq.com without delay. If Participant's medical situation changes at any point during the Study, Participant shall notify Sponsor at info@dusq.com.
Participation is voluntary. Participant may withdraw from the Study at any time by sending an email to info@dusq.com. Data collected prior to withdrawal may be retained and used in anonymised or aggregate form in the Study findings.
- There is no monetary payment for participation.
- Sponsor provides Participant with access to the DUSQ application and its features for the duration of the Study, on terms communicated separately.
- The Device provided to Participant for the Study is subject to terms that will be communicated separately, including terms relating to ownership and return upon conclusion of the Study or withdrawal.
9.1 Application-stage confidentiality
By accepting this Consent Form, Participant agrees that the contents of the Project 68 screening process, the Device, and any non-public information shared by Sponsor with Participant during the application stage are confidential. Until such information becomes publicly available through Sponsor or is otherwise lawfully made public, Participant shall not:
- Publicly disclose that Participant has applied to Project 68, except to immediate family or a treating physician on a need-to-know basis.
- Share, post, photograph, screenshot, or publish the screening questions, the Device, or any Sponsor materials provided during the application stage.
- Discuss Sponsor's pre-launch positioning, pricing, or product roadmap with any third party.
These obligations apply regardless of whether Participant is selected for the Study.
9.2 Non-Disclosure Agreement on selection
Participants selected for the Study shall execute a separate Non-Disclosure Agreement prior to commencing the Study. That Agreement governs Participant's confidentiality obligations during and after the Study period.
For all matters relating to the Study, contact info@dusq.com.
11.1 Voluntary participation.
Participant acknowledges and agrees that participation in the Study is entirely voluntary, that Participant has not been induced to participate by any representation or promise of medical benefit, and that Participant has elected to participate of Participant's own free will.
11.2 No medical advice; no diagnosis or treatment.
Participant acknowledges that the Device is not a prescription medical device, is not cleared or approved by the U.S. Food and Drug Administration or any other regulator to diagnose, treat, cure, or prevent any disease or medical condition, and that Sponsor has not provided Participant with medical advice. Participant is solely responsible for consulting a qualified healthcare professional regarding any health concern.
11.3 Participant representations and warranties.
Participant represents and warrants that:
- Participant is 18 years of age or older.
- Participant has read and understood the risks, discomforts, and contraindications set out in Section 6.
- Participant does not have any of the contraindications listed in Section 6.
- Participant has truthfully and completely answered all eligibility and screening questions.
- Participant is not aware of any medical condition that would make participation in the Study unsafe.
- Participant shall use the Device strictly in accordance with the instructions provided by Sponsor.
- Participant shall promptly notify Sponsor at info@dusq.com if any of the foregoing representations cease to be true during the Study.
11.4 Assumption of risk.
Participant knowingly, voluntarily, and expressly assumes all risks associated with participation in the Study and use of the Device, whether or not specifically identified in this Consent Form, and whether known or unknown, foreseeable or unforeseeable.
11.5 Release and waiver.
To the fullest extent permitted by applicable law, Participant, on behalf of Participant and Participant's heirs, executors, administrators, successors, and assigns, hereby releases, waives, discharges, and covenants not to sue Sponsor and its parent and affiliated entities, including Ezymind Healthcare Private Limited, and each of their respective officers, directors, employees, contractors, advisors, agents, and successors (collectively, the "Released Parties"), from any and all claims, demands, liabilities, losses, damages, costs, expenses, and causes of action of any kind, whether at law or in equity, and whether known or unknown, arising out of or relating in any way to Participant's participation in the Study, use of the Device, or the collection or use of Participant's data as described in this Consent Form. This release does not apply to claims arising from the gross negligence or wilful misconduct of a Released Party, or any other liability that may not be released as a matter of law.
11.6 Indemnification.
Participant shall indemnify, defend, and hold harmless the Released Parties from and against any claim, demand, liability, loss, damage, cost, or expense (including reasonable attorneys' fees) arising out of: (i) Participant's breach of any representation, warranty, covenant, or obligation under this Consent Form; (ii) Participant's misuse of the Device or failure to follow Sponsor's instructions; or (iii) Participant's failure to disclose a contraindication or material health condition.
11.7 No guarantee of results.
Participant acknowledges that Sponsor makes no representation or guarantee regarding any specific outcome, benefit, or change in sleep that Participant may or may not experience during the Study.
11.8 Use of likeness.
Sponsor shall not use Participant's name, image, voice, or likeness in any external publication without Participant's separate written authorisation.
11.9 Governing law.
This Consent Form is governed by the laws of the State of Delaware, without regard to its conflict of laws principles. The state and federal courts located in New Castle County, Delaware shall have exclusive jurisdiction over any dispute arising out of or relating to this Consent Form. Each party waives any objection to venue in such courts and any claim of inconvenient forum.
11.10 Severability and survival.
If any provision of this Consent Form is held invalid or unenforceable, the remaining provisions shall remain in full force and effect. Sections 4, 5, 6, 9, 10, and 11 survive completion or termination of the Study.
By submitting the Project 68 application form in which this Consent Form is presented, Participant acknowledges that Participant has read this Consent Form in full, understands its terms, has had the opportunity to ask questions and received satisfactory answers to any questions raised, and agrees to be bound by it. Participant further acknowledges that Participant does not have any of the contraindications listed in Section 6 and is participating voluntarily and at Participant's own risk.
Electronic consent submitted through the application form is legally binding to the same extent as a handwritten signature. The date and identity of the Participant are recorded automatically at the time of submission.