cluster:datasets:pilot_study [Sleep Revolution Wiki]

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====== 3-Month Pilot Study ======

===== Study aims =====



===== Study Protocol =====

Interested individuals answered an online questionnaire to evaluate if they met the criteria for participation.

Around 130 individuals were invited to participate, both men and women, in the age range of 18-99 years. Both healthy individuals, snoring individuals and those with suspected or confirmed sleep apnea were invited. The aim wasn to include individuals with a wide range of body mass index, age and gender. The participants were selected based on these criteria.

==== The research and preparation for the study ====

There will be 2visits that will take place at RU.

__First visit ( approx. 2.5 hours):__
The first visit started with the participant receiving an in-depth introduction to the study and then followed by the signing of an informed consent form. Next, the participant's height and weight was measured as well as body composition where the ratio of muscles and fat was estimated. The SleepRevolution app and Withings app was installed in the participant's mobile phone. The participant was asked to wear a smartwatch for 90 days and answer a sleep diary in the SleepRevolution app. Access was given to the website SleepWell (hosted by RU) where participants had access to their own data collected in the SleepRevolution app. Next the participants receives the sleep study equipment and gets an introduction to the sleep study and what it entails. The sleep study measured sleep stages, sleep quality, breathing, snoring, oxygen saturation, electrocardiogram, leg movements, body movements and position. The participant took the sleep study equipment home and applied it themselves and sleeps at home for three consecutive nights. Study is repeated for three nights in a row and the participant takes it off in the morning and applies again in the evening. At the end of the visit, participants will perform neurocognitive tests that measure cognitive abilities such as memory, attention and processing speed. The neurocognitive tests will take about 90 minutes to complete. The participant was further asked to fill out questionnaires assessing their experienced cognitive functioning, exercising, social functioning and mental health (anxiety, stress, depression and trauma). After three nights the equipment was returned to the RU reception.

__Second visit (approx. 2 hours):__
The Withings watch is returned. Body composition measurements and neurocognitive tests were repeated.

__Additional study:__
Participants were offered to perform an additional one night sleep study with the Nukute sleep collar, during the first night of the 3-night sleep study. The Nukute sleep collar measured breathing sounds, pulse and oxygen saturation.

__Post-study interview:__
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.|