Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)

Hypertension Clinical Trial

— SUPER-SHARP  

Official title:

Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918120
• Other study ID #: 5749
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: July 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Mark I Boulos, MD, MSc
• Phone: 4164804473
• Email: mark.boulos[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Uncontrolled hypertension is associated with an increased risk of heart disease, stroke, and mortality. Obstructive sleep apnea (OSA) is common in hypertension and treatment using continuous positive airway pressure (CPAP) has been shown to effectively lower blood pressure. Despite its clinical significance, OSA remains underdiagnosed in patients with hypertension, because the current standard of care to diagnose OSA is in-laboratory polysomnography, which is inconvenient and often inaccessible for high-risk populations. An alternative to in-laboratory polysomnography is home sleep apnea testing, which has been validated against in-laboratory polysomnography and may be more convenient, accessible, and potentially cost-effective. The objective of this study is to compare home sleep apnea testing to in-laboratory polysomnography in a randomized controlled trial. The investigators will assess whether the use of home sleep apnea testing, compared to use of in-laboratory polysomnography, leads to higher rates of OSA diagnosis and treatment using CPAP, a reduction in blood pressure, improved sleep-related outcomes, and greater patient satisfaction among patients with hypertension at 6 months. The investigators will also assess whether home testing is cost-effective.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: August 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (1) Hypertension, defined as:

• uncontrolled blood pressure on or off medications, or

• controlled blood pressure on 2 or more blood-pressure lowering medications

• (2) At high risk for OSA:

• STOP-BANG sleep apnea screening tool =3, or

• Concomitant renal disease (estimated glomerular filtration rate [eGFR] 15-59), or

• Resistant hypertension, defined as a blood pressure above target despite 3 or more BP-lowering drugs at optimal doses (preferably including a diuretic)

Exclusion Criteria:

• prior diagnosis of OSA, current use of CPAP, life expectancy less than 6 months, eGFR<15, gestational hypertension or preeclampsia, current use of dialysis, and physical/cognitive impairment/language barrier restricting the ability to complete the study assessments.

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Home Sleep Apnea Test
Use of a home sleep apnea test that records respiratory effort, pulse, oxygen saturation and nasal flow, and reports apneas, hypopneas, flow limitation, snoring and blood oxygen saturation in order to detect obstructive sleep apnea.
• In-laboratory polysomnography
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of OSA	The investigators will track the number of subjects in each arm who are diagnosed with OSA. Subjects who withdraw or are lost to follow-up without receiving a diagnosis of OSA will be included in our analysis as not having received an OSA diagnosis.	6 months
Secondary	Treatment using CPAP	The proportion of patients treated for OSA using CPAP	6 months
Secondary	Change in 24-hour ambulatory blood pressure	Change in 24-hour ambulatory blood pressure from baseline to 6 months	6 months
Secondary	Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)	Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) at 6 months. Functional Outcomes of Sleep Questionnaire (FOSQ) encompasses 5 subscales: activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome. An average score is calculated for each subscale and the 5 subscales are totaled to produce a total score. Subscale scores range from 1-4 with total scores ranging from 5-20. Higher scores indicate better functional status.	6 months
Secondary	Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)	Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months. Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).	6 months
Secondary	Patient satisfaction with sleep testing	Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) at 6 months. Scores range from 0-16, with higher scores indicating increased satisfaction.	6 months