NCT07469644

A Digital Mindfulness Intervention to Improve Sleep Efficiency and Heart Rate Variability in Healthy Adults

A Digital Mindfulness Intervention to Improve Sleep Efficiency and Heart Rate Variability in Healthy Adults: A Randomized Waitlist-Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep
• Heart Rate

Interventions

Type	Name	Description
BEHAVIORAL	App-based mindfulness program (Headspace via Ōura app)	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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-05-01
• Completion: 2024-08-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: Denmark