Research Summary

TITLE: The Six Weeks to Restoration (62R) Study

PRINCIPAL INVESTIGATORS: Gaurav Mishra, M.D. drgmishra@gmail.com, Terry Quinn terry@existtribe.com, Bardha Citaku bardha@existtribe.com, Robert Sweetman rob@existtribe.com

FUNDED BY: Existential Technologies, Inc. DBA Exist Tribe

PURPOSE: 62R is a long-term research program for assessing the outcomes of the 62R sessions, the REST NODE sleep companion, and recommended sleep practices. This study’s purpose is to better understand the potential for the 62R program to positively impact health and well-being.

PROCEDURES: You are eligible to participate in the Six Weeks to Restoration (62R) Study. After reviewing and completing this consent form, you may participate in the study, conducted remotely.

The study consists of a six-week sleep science educational workshop, intake questionnaire, six one-hour Zoom classes, daily sleep surveys, use of the REST NODE, use of a sleep tracking device, and an outtake questionnaire.

You will participate in an online sleep science education workshop while using the REST NODE. The experiment that will take place over six weeks (lectures each Sunday) on the Zoom video-conferencing platform. The workshop will be overseen by Dr. Gaurav Mishra M.D. and led by Robert Sweetman. Dr. Mishra is a Clinical Psychiatrist and Mr. Sweetman is a certified sleep science coach. The instruction will include lectures on sleep science, recommendations on sleep schedules, breathing exercises, guided meditations, and yoga nidra sessions. Each participant will also have the option of a 30 minute one-on-one call to help set up devices.

Each Sunday afternoon, you will connect to the Zoom meeting and listen and interact for one hour. Each night, for six weeks, the REST NODE will automatically turn on the nightlight and background sounds based on your preferences in the settings. Each morning the REST NODE will turn on the waking light and morning sounds based on your preferences. You will receive a daily sleep diary survey via email that needs to be completed that day. 

Mr. Quinn is the program manager for 62r. He and the research assistant, Bardha Citaku (6th year med student) will collect and review the daily sleep diaries. They will also collect and organize the Withings Sleep Mat data. This information will be kept confidential and handles in accordance with HIPAA regulation.

At the beginning of the workshop you be asked to complete these intake assessments. These are not required but could be of significant help to the study:

• Pittsburgh Sleep Quality Index (PSQI)

• Insomnia Severity Index Assessment (ISI)
• Patient Health Questionnaire-9 (PHQ-9)
• Generalized Anxiety Disorder 7-item (GAD-7)
• The PTSD Checklist (PCL-5) (Veteran Cohort Only)

Each day throughout the workshop you will complete these measures: 

• Sleep Diary (3 Questions)
• Sleep Measurements automatically provided from Withings Sleep Mat.

At the conclusion of the workshop you be asked to complete these out-take assessments. These are not required but could be of significant help to the study:

• Pittsburgh Sleep Quality Index (PSQI)

• Insomnia Severity Index Assessment (ISI)
• Patient Health Questionnaire-9 (PHQ-9)
• Generalized Anxiety Disorder 7-item (GAD-7)
• The PTSD Checklist (PCL-5) 
(Veteran Cohort Only)

ACCESS TO YOUR TEST RESULTS: You will have access to your sleep diary and sleep measurements. You will not be able to see anyone else's data or the groups data. 

RISKS AND DISCOMFORTS: This is a minimal risk study. Your comfort and safety is of the utmost importance and protection against risk will occur at many levels. Your participation is strictly voluntary and you may discontinue the study activities at any time.

BENEFITS: The findings from this study may contribute to sleep science and of the potential of the 62R program as a healing modality. It will also serve as the basis and the ongoing refinement of 62R curriculum – exploring what works, for whom, and under what conditions.