Apollo Remote Observational Sleep Study

NCT05260489 | Withdrawn

• 2 other identifiers: AN00120214102
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine how Transcutaneous Vibratory Stimulation (TVS) produced by the Apollo wearable affects sleep and cardiovascular function in a diverse real-world population of Apollo users.

Conditions

Sleep Quality; Heart Rate

Keywords

sleep quality, HRV, tvs, wearable

Outcome Measures

Primary Outcomes (10)

• Average Heart Rate during sleep

  The average heart rate measured during sleep in beats per minute

  Through study completion, an average of 4 years

• Heart Rate Variability during sleep

  The Heart Rate Variability value measured during sleep in milli seconds

  Through study completion, an average of 4 years

• Lowest Heart Rate during sleep

  The lowest Heart Rate measured during sleep in beats per minutes

  Through study completion, an average of 4 years

• Sleep Onset

  The amount of time it takes to fall asleep once you are on the bed in seconds

  Through study completion, an average of 4 years

• Sleep efficiency

  The proportion of time spent sleeping to total time in bed

  Through study completion, an average of 4 years

• Wake time during sleep

  Total amount of time spent awake during a sleep session in seconds

  Through study completion, an average of 4 years

• Sleep duration

  Total amount of time spent sleeping in seconds

  Through study completion, an average of 4 years

• Deep sleep duration

  Total amount of time spent in deep sleep during sleep sessions in seconds

  Through study completion, an average of 4 years

• REM sleep duration

  Total amount of time spent in REM sleep during sleep sessions in seconds

  Through study completion, an average of 4 years

• Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. With a range of scores 1-21.

  Through study completion, an average of 4 years

Secondary Outcomes (1)

• Oura Sleep Score

  Through study completion, an average of 4 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Current Apollo Neuro customers who own and use Oura ring devices

You may qualify if:

• Aged 18 or more
• Use both the Apollo wearable and Oura ring

You may not qualify if:

• Inability to complete questionnaires written in English.

Sponsors & Collaborators

• Apollo Neuroscience, Inc.: lead

Study Sites (1)

Apollo Neuroscience, Inc.

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• David Rabin, MD PHD

  Apollo Neuroscience, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 2, 2022
• Study Start: January 18, 2022
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)