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--- cluster:datasets:lifestyle [2023/08/31 15:14] – created katrinhera
+++ cluster:datasets:lifestyle [2025/02/18 09:53] (current) – katrinhera
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 ====== Prospective Lifestyle Study ======
+===== Study aims =====
+This study aimed to improve habitual snoring to mild sleep apnea through lifestyle intervention that involves sleep studies, neurocognitive testing, evaluation of body composition and physical fitness, physiological data collected with a smartwatch, questionnaires, and a sleep diary. The study will not only allow for the evaluation of a new lifestyle program for mild sleep apnea but is also helping to validate the used equipment, as well as contribute to the understanding of sleep and its related scientific fields.
+===== Study Protocol =====
+Around 200 individuals aged 18 – 40 will be invited to participate. Inclusion criteria are a BMI ≥ 25, physical inactivity, and confirmed habitual snoring to mild sleep apnea. Shift workers can not participate.
+Participants will be divided randomly into three intervention groups:
+  - Exercises in a group with a coach for 12 weeks (3x week, 60 min)
+  - Regular use of instructions from the SideKick Health app for 12 weeks
+  - Regular use of the Sleep Revolution App for 12 weeks
+==== The research and preparation for the study ====
+Participants that fulfil the inclusion criteria of the study will be chosen from the people that have answered the screening list (https://svefnsetrid.ru.is/en). Some of them have already participated in sleep studies from previous projects in the Sleep Revolution or have sleep study from collaborators but those that do not have a sleep study needs to undergo a screening sleep study to confirm snoring to mild/moderate sleep apnea. All chosen participants will be asked to wear a smartwatch and fill in a sleep diary for 2 weeks prior to the intervention period to get a baseline.
+Participants will be asked to answer a background questionnaire; a personalized link will be sent via e-mail.
+There will be 5-7 visits (depending on groups) that will take place at RU.
+==== Visits after participants have been divided into groups ====
+__First visit (approx. 1.5 hours):__
+A neurocognitive test battery will be performed at RU. The battery measures various cognitive domains.
+Simultaneously as the tasks are done, brainwaves,heart rate, breathing and sweating are monitored with measuring equipment that is placed on the participants before the tasks start.
+Participants will be handed equipment for a three-night sleep measurement. The equipment is returned after the last measurement night.
+Smartwatches are handed out to participants for use during the intervention period.
+__Second visit (approx. 1 hour):__
+First day of the intervention period. A baseline measurement of physical factors.
+  - Anthropometric measurements
+  - Body Composition measurements
+  - Physical fitness measurements
+  - Questionnaires answered at home (a link sent via e-mail)
+  -
+__At home, during the intervention period (12 weeks)__
+Participants are asked to:
+  - Wear a smartwatch provided for the entirety of the study
+  - Answer daily a sleep diary (evening and morning) within the Sleep Revolution app.
+  - Perform cognitive tasks which measure attention, vigilance, and more within the Sleep Revolution app and the Sleep Revolution platform ( in the beguinning, after week four and eight and after the invention period).
+  - Track the menstrual cycle of female participants within the Sleep Revolution app.
+  - Fill out questionnaires three times during the intervention period (after the first visit, week 6, and week 12). The questionnaires will assess exercise, mental health (stress, depression, anxiety, trauma), self-reported cognitive functioning, and self-reported quality of life.
+__Third visit (1 hour):__
+Last day of the intervention period
+  - Anthropometric measurements
+  - Body Composition measurements
+  - Physical fitness measurements
+  - Questionnaires answered at home (a link sent via e-mail)
+__Fourth visit (1.5 hours)__
+The cognitive battery is repeated in Reykjavik University
+Equipment for the three-night sleep study that is repeated at the end of the intervention period will be handed out.
+The equipment and the smartwatch are returned after the last measurement night.
+__Fifth visit (In RU or on Teams)__
+An interview about the experience that the participant has had of the study. Audio recording will be done in the interview and will be deleted after transcription of it.
+===== Summary of the collected data: =====
+|**Sleep studies:**| Sleep stages, sleep quality, breathing, snoring (audio), oxygen desaturation, electrocardiogram, leg movements, body movements, sleep position.|
+|**Cognitive battery and brain games:**| Cognitive functioning is measured through a variety of domains such as memory, attention, processing speed, emotional recognition, working memory, etc.|
+|**Anthropometry, body composition, physical fitness:**| Height, weight, body mass index (BMI), waist-hip ratio, neck circumference, bioelectrical impedance analysis (BIA), grip strength, and 6-minute walking test.|
+|**Withings smartwatch:**| Heart rate, movement, sleep, oxygen saturation.|
+|**Sleep Revolution app:**| Daily sleep diary, lifestyle (caffeine intake, naps, etc.), brain games, menstrual cycle in women.|
+|**Sleep Revolution digital platform:**| Overview of collected data, brain games.|
+|**Questionnaires:**| Mental health (stress, depression, anxiety, trauma), self-reported cognitive functioning, self-reported quality of life, and end-user experience of sleep equipment.|
+|**Interview:**| Participants experience of the study.|