University of Southern Denmark. Department of Psychology.
Odense, 5230, Denmark
NCT Number: NCT07469644
This study tested whether a 10-day smartphone app-based mindfulness program can improve sleep and reduce physiological stress in healthy adults. Eighty-one healthy adults were randomly assigned to either a mindfulness group (completing a daily 10-minute guided session via the Ōura app for 10 days) or a waitlist control group. All participants wore an Ōura Ring throughout the study to objectively measure sleep and heart rate variability (HRV). Questionnaires on perceived stress, sleep quality, burnout, and mindfulness were completed before, immediately after, and four weeks after the intervention. The study was conducted at the University of Southern Denmark.
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Odense, 5230, Denmark
This randomized controlled trial (RCT) used a waitlist-controlled design to examine whether a 10-day smartphone app-based mindfulness program could improve sleep and reduce physiological stress markers in healthy adults. The study was embedded within a broader 4-month longitudinal cohort study (N=140); the RCT sub-study focused on participants in the low-stress stratum (Perceived Stress Scale [PSS-10] ≤13) at screening. Participants (n=81) were randomized in approximately a 3:2 ratio to either a mindfulness intervention group (n=49) or a waitlist control group (n=32). The mindfulness group completed one 10-minute guided audio session daily ("destress" module, narrated by Headspace) delivered via the Ōura app for 10 consecutive days in free-living conditions at a time of their own choosing. Compliance was monitored objectively via app-recorded session timestamps. The waitlist control group wore the Ōura Ring and completed all questionnaires identically without receiving any intervention. All participants wore an Ōura Ring Gen 3 throughout the study to objectively and continuously measure sleep architecture, sleep efficiency, and heart rate variability (HRV). Self-report questionnaires on perceived stress (Perceived Stress Scale; PSS-10), sleep quality (Pittsburgh Sleep Quality Index; PSQI), burnout (Copenhagen Burnout Inventory; CBI), and mindful attention (Mindful Attention Awareness Scale; MAAS) were administered before, immediately after, and four weeks after the 10-day intervention period. The study was conducted at the University of Southern Denmark, Odense, Denmark.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants completed one 10-minute guided audio mindfulness session daily ("destress" module, narrated by Headspace) delivered via the Ōura app for 10 consecutive days in free-living conditions at a time of their own choosing. Compliance was monitored objectively via app session timestamps.
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10); 4-week follow-up (Time 2: days 22-28 of follow-up)
Percentage of time asleep relative to total time in bed, measured continuously by Ōura Ring Gen 3 (accelerometry and photoplethysmography); computed as 7-day averages at each assessment timepoint.
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10); 4-week follow-up (Time 2: days 22-28 of follow-up)
Minutes asleep per night, measured by Ōura Ring Gen 3.
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10); 4-week follow-up (Time 2: days 22-28 of follow-up)
Minutes of slow-wave sleep per night, measured by Ōura Ring Gen 3.
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10); 4-week follow-up (Time 2: days 22-28 of follow-up)
Minutes of non-rapid eye movement (NREM) light sleep per night, measured by Ōura Ring Gen 3.
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10); 4-week follow-up (Time 2: days 22-28 of follow-up)
Clock time of sleep onset, measured by Ōura Ring Gen 3.
Time frame: Daily during 10-day intervention period
Root mean square of successive differences (RMSSD) (ms) measured during 10-min mindfulness sessions compared to an equivalent pre-session baseline period, assessed by Ōura Ring Gen 3.
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10); 4-week follow-up (Time 2: days 22-28 of follow-up)
Perceived Stress Scale (PSS-10). Self-report questionnaire; sum score 0-40.
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10); 4-week follow-up (Time 2: days 22-28 of follow-up)
Pittsburgh Sleep Quality Index (PSQI). Self-report questionnaire; global score 0-21.
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10); 4-week follow-up (Time 2: days 22-28 of follow-up)
Copenhagen Burnout Inventory (CBI). Self-report questionnaire; subscale scores 0-100%.
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10)
Mindful Attention Awareness Scale (MAAS). Self-report questionnaire; sum score 15-90. Administered to the mindfulness intervention group only.
University of Southern Denmark
Other
A Digital Mindfulness Intervention to Improve Sleep Efficiency and Heart Rate Variability in Healthy Adults: A Randomized Waitlist-Controlled Trial
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