TITLE OF STUDY

Exploring the Correlation Between Sleep Spasticity on Perceived Stress Levels and Cognitive Flexibility among Multiple Sclerosis Patients Aged 30 to 60 in Texas

PRINCIPAL INVESTIGATOR
Maitreyi Madhira

Independence High School

10555 Independence Pkwy, Frisco, TX 75035

469-633-5400

maitreyi.madhira.956@k12.friscoisd.org

PURPOSE OF STUDY
The purpose of this study is to establish a possible correlation between sleep-spasticity induced stress and cognitive flexibility among patients diagnosed with Multiple Sclerosis between the ages of 30 and 60. Sleep spasticity is a symptom of multiple sclerosis that can be characterized by muscle tension and stiffness, which can lead to disturbances in sleep or the ability to gain adequate rest. As a result, this condition can often lead to stress among patients. This study examines whether this stress plays a part in cognitive flexibility, a specific aspect of cognition. To elaborate, cognitive flexibility is typically defined by the ability of individuals to adapt their behaviors as a response to changing environments or environments that differ from their usual lifestyles. Due to feelings of sleep discomfort, patients tend to experience an increase in stress. This may, in turn, be associated with diminished ability to accommodate to new circumstances, so I intend to find out if sleep-spasticity induced stress is potentially influencing Multiple Sclerosis patients' ability to adjust and adapt to daily responsibilities.

STUDY PROCEDURES
In this study, Multiple Sclerosis patients from various support groups (both in-person and online) in the Dallas-Fort Worth area will be interviewed regarding their experience with MS, specifically focusing on nighttime disturbances, its effects on their mood, and their opinions on cognitive flexibilities or, in other words, their ability to carry out daily tasks following these disturbances. The questions will be grouped into 4 main categories: General Experience with MS, Muscle Spasms at Night and Its Impacts on Sleep Quality, Understanding Perceived Stress Levels through Perceptions of Mood, and Looking into Cognitive Flexibility. The first category of questions is designed to ease the patient into talking about their experiences with the condition. Following this, each of the sections gets slightly more narrow in order to understand patient opinions on cognitive flexibility specifically. Within the third category, patients will not be directly asked about their mental well-being. Rather, they will be asked about their mood given certain structured scenarios where they will be required to rank the scenarios. The interview questions will also be open-ended in order to allow patients to answer each question to the best of their comfort levels. Interviews will be conducted virtually either through a phone call or an online meeting platform. In order to schedule the interviews, patients will be able to give their preferred time and date through email. Each interview will be recorded and later transcribed to maintain the integrity of the research and ensure that no details are neglected. Finally, at no point in the interview will a participant be forced to answer any of the questions. Furthermore, no identifying information such as name and address will be used for the research. Participation is completely voluntary as well, and prior to each interview, each patient must fill out a consent form, acknowledging that their information will not be disclosed and that any information shared regarding general medical history or their condition is fully voluntary.

RISKS
The risk involved in this study is minimal. Participants of the interviews may have to look at a computer screen for 30 to 60 minutes for the duration of the interview if an online meeting platform is chosen. However, this is an activity that many adults already participate in, therefore posing little to no risk. Additionally, a few topics discussed in this study may be sensitive for certain patients. That being said, participation in this study is completely voluntary, and if a particular question makes a patient uncomfortable, then they may stop the interview or skip the question without any consequence. The questions asked in the interview will also aim to be non-invasive, avoiding questions delving into details about the patient's personal lives.

BENEFITS
The interviews conducted during this study pose no direct benefits to Multiple Sclerosis patients. However, the primary purpose of this study is to explore the possibility of a correlation between sleep-spasticity induced stress and cognitive flexibility, which could help patients by increasing the presence of literature on the challenges faced by Multiple Sclerosis, specific to certain symptoms. If the study shows that sleep-spasticity-induced stress can be associated with cognitive flexibility, then future research on interventions could possibly aim to address these factors for Multiple Sclerosis patients. If, however, there is no correlation, then the study does not offer benefits to the subjects, direct or indirect.

CONFIDENTIALITY

Your responses to this study will be anonymous. Every effort will be made by the researcher to preserve your confidentiality, including the following:

• No names or identifying information will be noted or recorded. Code names/numbers will be assigned for participants that will be used on all research notes and documents. No personal identifiers will be attached to any of the information disclosed in the interviews.
• Notes, interview transcriptions, recordings, and any other identifying participant information will be in a locked drive file with a password in the personal possession of the researcher. This way, they will be secure and safe from being shared with public entities. In the event that any information is used for future research, no identifiers will be shared. The data will be completely anonymized.
• Participation in this study is purely voluntary and you may choose to share only the information you are comfortable sharing. You may also choose to stop the interview at any given point in time without any consequences.

Participant data will be kept confidential except in cases where the researcher is legally obligated to report specific incidents. These incidents include, but may not be limited to, incidents of abuse and suicide risk.

CONTACT INFORMATION
If you have questions at any time about this study, or you experience adverse effects as a result of participating in this study, you may contact the researcher whose contact information is provided on the first page. If you have questions regarding your rights as a research participant or if problems arise that you do not feel you can discuss with the Primary Investigator, please contact the AP Research teacher, Mrs. Sinclair, at sinclairg@friscoisd.org.

VOLUNTARY PARTICIPATION
Your participation in this study is voluntary. It is up to you to decide whether or not to take part in this study. If you decide to take part in this study, you will be asked to sign a consent form. After you sign the consent form, you are still free to withdraw at any time without giving a reason. Withdrawing from this study will not affect the relationship you have, if any, with the researcher. If you withdraw from the study before data collection is completed, your data will be returned to you or destroyed. 

CONSENT

I have read and I understand the provided information and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. I understand that I will be given a copy of this consent form. I voluntarily agree to take part in this study.

Participant's signature ______________________________ Date __________