An interventional study of Heart rate feedback from smartwatch in Interoceptive Awareness, Interoception and Alexithymia, sponsored by Massachusetts Institute of Technology. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Massachusetts Institute of Technology · Not applicable, Interventional, and Basic science
Among 28 studies in Affective Symptoms with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Affective Symptoms · United States.
Among the 28 studies in Affective Symptoms with a site in United States, this one is the 20th largest by enrollment of the 27 interventional ones, is one of 3 that started in 2025, is one of 24 with no phase, and was the 28th registered.
85 studies on the registry are indexed under Affective Symptoms; 20 are open to participants now.
This study's enrollment of 29 is below the median of 80 across 63 interventional studies indexed under Affective Symptoms.
Browse Affective Symptoms studies →4 of the 28 studies in Affective Symptoms with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 11 Affective Symptoms studies recruiting now, 4 (36%) set no upper age limit and 7 (64%) stop at 75 or younger; 5 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →28 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2025.
Median enrollment 50 across the 27 interventional studies, 53 across the 1 observational. Of the 23 that completed or were terminated, 4 (17%) have results posted.
1 of 28 have an industry lead sponsor. The 10 most frequent:
Massachusetts Institute of Technology is the lead sponsor of 34 studies on the registry; 11 are open to participants now.
Massachusetts Institute of Technology has 1 study filed under Affective Symptoms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 28 studies in Affective Symptoms with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study investigates the relationship between heart-beat haptic feedback on interoceptive awareness and mental-wellbeing. Previous research showed non-significant results in short-term emotion regulation tasks when given heartbeat haptic feedback, suggesting the need for an extended adjustment training period to build trust with interoceptive feedback systems. To address this, the experimenters propose an in-the-wild study where participants wear a Bangle.js smartwatch for one week each under two conditions: (1) Real heartbeat feedback and (2) Off-set heartbeat feedback. This design aims to examine the influence of haptic feedback on psychological characteristics, including alexithymia, anhedonia, depression, anxiety, and general mental health. The experimenters will also explore the usability and comfort levels related to prolonged wearable use, as well as the participants' ability to distinguish between real and off-set heartbeat feedback, particularly across different levels of alexithymia traits.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants wear a smartwatch during all waking hours which delivers vibration pulses at a frequency matching the current heart rate sensed by the smartwatch
Device: Heart rate feedback from smartwatch
Participants wear a smartwatch during all waking hours which delivers vibration pulses at a frequency matching the heart rate from one hour ago as measured by the smartwatch. The time delay means that feedback does not match the current heartrate but maintains the overall descriptive statistics of the participant's heartbeat.
Device: Heart rate feedback from smartwatch
Participants wear a smartwatch during their waking hours which delivers pulses of vibration which can be matched to the frequency of the current heart rate (real condition) or heart rate from one hour ago (sham condition)
Center for Epidemiological Studies-Depression Scale
Measured by the standard scoring procedure in each lab visit at the start of the week. Decrease is considered an improvement.
Time frame: Difference from measurement at the start of each arm to end of each arm (1 week span)
Interoceptive accuracy
Interoceptive accuracy measured using SensHb (slope of the correlation of estimated heart rate with smartwatch-recorded heart rate measured over three 1-minute measurement periods during the in-lab questionnaire)
Time frame: 1 week (difference between SensHB at the start of each arm and the end of each arm)
Snaith-Hamilton Pleasure Scale
Measured at the lab visit at the start of each week. We sum the pleasure rating for each item so the score represents overall hedonic capacity (opposite of anhedonia). Increase is considered improvement
Time frame: Difference from measurement at the start of each arm to end of each arm (1 week span)
General Anxiety Disorder-7 Anxiety Scale
Measured by the standard scoring procedure in each lab visit at the start of the week. Decrease is considered an improvement.
Time frame: Difference from measurement at the start of each arm to end of each arm (1 week span)
Toronto Alexithymia Scale-20 Alexithymia Scale
Measured by the standard scoring procedure in each lab visit at the start of the week. Decrease is considered an improvement.
Time frame: Difference from measurement at the start of each arm to end of each arm (1 week span)
General Health Questionnaire-12 General Mental Distress scale
Measured by the standard scoring procedure in each lab visit at the start of the week. Decrease is considered an improvement.
Time frame: Difference from measurement at the start of each arm to end of each arm (1 week span)
Interoceptive confidence
Self rated confidence in the accuracy of heartbeat count
Time frame: 1 week (measure difference between start and end of each arm)
Interoceptive awareness
Multidimensional Assessment of Interoceptive Awareness -2 total score. Increase indicates improved interoceptive awareness.
Time frame: Start of each arm to end of each arm (1 week)
Daily mood
Brief Mood Introspection Scale (BMIS) positive-negative axis measured each day. Increase indicates increased positive affect.
Time frame: 1 week (measured each day of the arm)
Daily mood variability
Standard deviation of the Brief Mood Introspection Scale (BMIS) positive-negative mood axis across all the days in an arm. Increase indicates increased emotional variability.
Time frame: 1 week (measured each day of the arm)
Plan to share: Yes — Defidentified individual survey responses and sensHB accuracy data and analysis code
Supporting information: Statistical analysis plan, Analytic code
Time frame: Available indefinitely beginning March 2026
Access criteria: Data are available to the general public. Data and analysis scripts can be found at https://osf.io/wfexj/overview and the preregistered analysis plan can be found at https://aspredicted.org/hnyw-cw85.pdf
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Sep 2025, 2 months.
Of 44 non-industry interventional studies with no phase under Affective Symptoms, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's 2 months is below that.
Counting every sponsor, half of 44 studies reached it within 21 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Massachusetts Institute of Technology