Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05115305
Other study ID # ProdigyValidationStudy
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2022
Est. completion date April 9, 2022

Study information

Verified date July 2022
Source Cerebra Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Prodigy system, developed by Cerebra Medical Ltd, allows for the generation of the same information in the home that is currently only obtained in in-laboratory studies. The objective of the current study is to demonstrate that the signals obtained by this comprehensive, portable system are comparable to those obtained in in-laboratory studies.


Description:

This study consists of obtaining standard polysomnography signals concurrently by the Prodigy 2 and by the standard commercial systems used in the Sleep Disorders Clinic (Alice G3) in Hamilton, ON and the St. Charles Sleep Disorders Center (Nihon Kohden) in Port Jefferson, NY. 42 patients will be recruited from each of the two sites, for a total of 84 patients. Questionnaires on demographics and mental health, including the Depression Anxiety Stress Scale-21, questionnaires on sleep and fatigue including Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Epworth Sleepiness Scale and questionnaires on quality of life including the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) and the Euroquol 5D-5L will be completed online using a survey platform (Qualtrics or RedCap).


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date April 9, 2022
Est. primary completion date April 9, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients undergoing a diagnostic sleep test Exclusion Criteria: - in-hospital patients - subjects who self-report a previous diagnosis of neuromuscular disorders, obesity hypoventilation, or severe lung disease - subjects who are not fluent in English, or who have special communication needs - subjects who have dementia/Alzheimer's disease - subjects with comorbid violent parasomnias - subjects requiring additional assistance or who have limited ability follow commands.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Hamilton Sleep Disorders Clinic Hamilton Ontario
United States St Charles Sleep Disorders Center Port Jefferson New York

Sponsors (1)

Lead Sponsor Collaborator
Cerebra Medical

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (6)

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. — View Citation

Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. — View Citation

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. — View Citation

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. — View Citation

Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total Sleep Time To compare Level 1 and Level 2 sleep tests on TST Concurrent measurement for one night
Primary Apnea-Hypopnea Index To compare Level 1 and Level 2 sleep tests on AHI Concurrent measurement for one night
Primary Periodic Limb Movement Index To visually compare Level 1 and Level 2 sleep tests on PLM Concurrent measurement for one night
Secondary Signal Quality To compare signal quality between Level 1 and Level 2 sleep tests Concurrent measurement for one night
See also
  Status Clinical Trial Phase
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Recruiting NCT03919955 - A Novel Pharmacological Therapy for Obstructive Sleep Apnea Phase 2
Completed NCT03927547 - Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT01503164 - Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism N/A
Recruiting NCT00747890 - Surgical Treatment of Mild Obstructive Sleep Apnea N/A
Active, not recruiting NCT00738179 - Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease Phase 3
Completed NCT00841906 - Alice PDx User/Validation Extended Trial N/A
Completed NCT00202501 - Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome N/A
Completed NCT00047463 - Effects of Treating Obstructive Sleep Apnea in Epilepsy Phase 2
Not yet recruiting NCT06029881 - Portable System for Non-intrusive Monitoring of Sleep
Recruiting NCT06093347 - Central Apnoea Monitor Study
Terminated NCT05445869 - Severe OSA Study (SOS) N/A
Withdrawn NCT04096261 - The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Recruiting NCT04575740 - Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea N/A
Completed NCT04676191 - Validation of a Contactless Vital Signs Measurement Sensor N/A
Recruiting NCT06015620 - Comorbidities Resolution After MGB Surgery and Change in Body Composition
Completed NCT06051097 - Metabolic Syndrome and Obstructive Sleep Apnea
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury