NCT05129007

Brief Summary

The objective of this research study is to show whether data given by Oura ring could be used to objectively measure patients pain and well-being before and after disc surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

September 17, 2021

Last Update Submit

April 13, 2023

Conditions

Pain Measurement

Keywords

PainOura ringActivity measurmentHerniated disc

Outcome Measures

Primary Outcomes (9)

  • Change in heart rate variability

    collected from Oura ring

    comparison of mean value prior to surgery and one month after surgery

  • Change in resting mean heart rate

    collected from Oura ring

    comparison of mean value prior to surgery and one month after surgery

  • Change in ventilatory rate

    collected from oura ring

    comparison of mean value prior to surgery and one month after surgery

  • Change in sleep onset latency

    collected from oura ring

    comparison of mean value prior to surgery and one month after surgery

  • Change in sleep efficiency

    percentage of the time spent asleep while in bed collected from oura ring

    comparison of mean value prior to surgery and one month after surgery

  • Change in number of nighttime awakenings

    collected from oura ring

    comparison of mean value prior to surgery and one month after surgery

  • Change in total sleep time

    collected from oura ring

    comparison of mean value prior to surgery and one month after surgery

  • Change in sleep stages (awake, light sleep, deep sleep and rem sleep)

    percentages of each sleep stages collected from oura ring

    comparison of mean value prior to surgery and one month after surgery

  • Change in symptoms based on symptom diary

    Daily symptom diary kept by patient

    prior surgery and one month after surgery

Secondary Outcomes (2)

  • Change in BDI questionnaire points

    one month prior surgery and one month after surgery

  • Change in pain questionnaire

    one month prior surgery and one month after surgery

Study Arms (1)

Study group

All patients

Device: Oura ring

Interventions

Oura ringDEVICE

Photopletysmography based noninvasive device

Also known as: Pain questionnaire, BDI-questionnaire
Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients from Finland

You may qualify if:

  • Upcoming herniated disc surgery, ability to give a written informed concent

You may not qualify if:

  • Sleep apnea, Condition with irregular heart rate, lack of cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere university hospital

Tampere, Pirkanmaa, 33521, Finland

RECRUITING

MeSH Terms

Conditions

PainIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Central Study Contacts

Tommi Bergman, Md

CONTACT

0331166356tommi.bergman@pshp.fi

Jarkko Harju, md, phd

CONTACT

jarkko.harju@fimnet.fi

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

November 22, 2021

Study Start

November 1, 2022

Primary Completion

December 30, 2023

Study Completion

December 31, 2024

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)