SleepNCT07469644
A Digital Mindfulness Intervention to Improve Sleep Efficiency and Heart Rate Variability in Healthy Adults
A study testing App-based mindfulness program (Headspace via Ōura app) in people with Sleep and Heart Rate, run by University of Southern Denmark at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Heart Rate
- What is being tested?
- App-based mindfulness program (Headspace via Ōura app)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 20-60 years
- Body mass index (BMI) in normal range (18.5-29.9 kg/m²)
- Low stress at screening (Perceived Stress Scale (PSS-10) score ≤13)
- Willingness to wear the Ōura Ring continuously throughout the study
- No current regular mindfulness practice (defined as >20 min/week)
- Ability to provide written informed consent
- Sufficient Danish or English language proficiency
Who cannot join
- Current regular mindfulness or meditation practice >20 min/week
- Self-reported diagnosis of cardiovascular or neurodegenerative disease
- Current diagnosis of anxiety or depressive disorder
- Use of psychotropic medications, hypnotics, or medications affecting heart rate variability (HRV) or sleep
- Pregnancy
- Shift work or highly irregular sleep schedules
- Concurrent participation in another mindfulness or behavioral sleep intervention
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Southern Denmark. Department of Psychology.
Odense, 5230
About this study
Official title: A Digital Mindfulness Intervention to Improve Sleep Efficiency and Heart Rate Variability in Healthy Adults: A Randomized Waitlist-Controlled Trial
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.
Read the 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
- Being tested
- App-based mindfulness program (Headspace via Ōura app)
- Keywords
- Mindfulness, Sleep Efficiency, Heart Rate Variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based mindfulness program (Headspace via Ōura app)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention | Experimental | Participants completed a 10-day app-based mindfulness program (one 10-min guided session/day via Ōura app) in free-living conditions. Receives: Behavioral: App-based mindfulness program (Headspace via Ōura app) |
| Waitlist Control | No intervention | Participants wore the Ōura Ring and completed all assessments without receiving any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
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.
Measured: 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)
Secondary outcomes (9)
Total Sleep Time
Minutes asleep per night, measured by Ōura Ring Gen 3.
Measured: 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)
Deep Sleep Duration
Minutes of slow-wave sleep per night, measured by Ōura Ring Gen 3.
Measured: 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)
Light Sleep Duration
Minutes of non-rapid eye movement (NREM) light sleep per night, measured by Ōura Ring Gen 3.
Measured: 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)
Sleep Onset Time
Clock time of sleep onset, measured by Ōura Ring Gen 3.
Measured: 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)
Heart Rate Variability (HRV)
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.
Measured: Daily during 10-day intervention period
Perceived Stress Scale (PSS-10)
Perceived Stress Scale (PSS-10). Self-report questionnaire; sum score 0-40.
Measured: 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)
Pittsburgh Sleep Quality Index (PSQI). Self-report questionnaire; global score 0-21.
Measured: 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)
Copenhagen Burnout Inventory (CBI). Self-report questionnaire; subscale scores 0-100%.
Measured: 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)
Mindful Attention Awareness Scale (MAAS)
Mindful Attention Awareness Scale (MAAS). Self-report questionnaire; sum score 15-90. Administered to the mindfulness intervention group only.
Measured: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Dec 2023
- Primary completion1 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Kirk, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469644
- Sponsor's protocol ID
- 21345
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available from the corresponding author (Ulrich Kirk; ukirk@health.sdu.dk) on reasonable request. Data sharing will comply with the Danish Data Protection Act and General Data Protection Regulation (GDPR) (Regulation EU 2016/679).
Publications
Kirk U, Hovgaard CN, Persiani MTL, Romagnoli M, Staiano W. A digital mindfulness intervention improves sleep efficiency and heart rate variability in healthy adults. Sci Rep. 2026 Mar 21;16(1):14348. doi: 10.1038/s41598-026-44902-w.
PubMed 41862627
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Mindfulness Intervention to Improve Sleep Efficiency and Heart Rate Variability in Healthy Adults: A Randomized Waitlist-Controlled Trial
- ClinicalTrials.gov ID
- NCT07469644
- Acronym / sponsor ID
- 21345
- Conditions
- Sleep, Heart Rate
- Keywords
- Mindfulness, Sleep Efficiency, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention | Experimental | Behavioral: App-based mindfulness program (Headspace via Ōura app)Participants completed a 10-day app-based mindfulness program (one 10-min guided session/day via Ōura app) in free-living conditions. |
| Waitlist Control | No intervention | –Participants wore the Ōura Ring and completed all assessments without receiving any intervention. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 20-60 years
- Body mass index (BMI) in normal range (18.5-29.9 kg/m²)
- Low stress at screening (Perceived Stress Scale (PSS-10) score ≤13)
- Willingness to wear the Ōura Ring continuously throughout the study
- No current regular mindfulness practice (defined as >20 min/week)
Key exclusion criteria (7 listed)
- Current regular mindfulness or meditation practice >20 min/week
- Self-reported diagnosis of cardiovascular or neurodegenerative disease
- Current diagnosis of anxiety or depressive disorder
- Use of psychotropic medications, hypnotics, or medications affecting heart rate variability (HRV) or sleep
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness Intervention |
Primary outcome
Sleep Efficiency
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.
9 secondary outcomes
Total Sleep Time
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)
Deep Sleep Duration
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)
Light Sleep Duration
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)
Sleep Onset Time
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)
Heart Rate Variability (HRV)
Time frame: Daily during 10-day intervention period
Perceived Stress Scale (PSS-10)
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)
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)
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)
Mindful Attention Awareness Scale (MAAS)
Time frame: Pre-intervention (Time 0: 7-day average immediately before Day 1); post-intervention (Time 1: 7-day average immediately after Day 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 41862627Kirk U, Hovgaard CN, Persiani MTL, Romagnoli M, Staiano W. A digital mindfulness intervention improves sleep efficiency and heart rate variability in healthy adults. Sci Rep. 2026 Mar 21;16(1):14348. doi: 10.1038/s41598-026-44902-w.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available from the corresponding author (Ulrich Kirk; ukirk@health.sdu.dk) on reasonable request. Data sharing will comply with the Danish Data Protection Act and General Data Protection Regulation (GDPR) (Regulation EU 2016/679).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Kirk, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based mindfulness program (Headspace via Ōura app) in people with Sleep and Heart Rate, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07469644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.