Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05918120

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obstructive Sleep Apnea Apnea Cardiovascular Diseases Dyssomnias Hypertension Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citrus Medical Clinic, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home Sleep Apnea Test

Device

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.

Other names: HSAT

In-laboratory polysomnography

Device

Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.

Other names: iPSG

Primary outcomes

  1. Diagnosis of OSA

    Time frame: 6 months

    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.

Secondary outcomes

  1. Treatment using CPAP

    Time frame: 6 months

    The proportion of patients treated for OSA using CPAP

  2. Change in 24-hour ambulatory blood pressure

    Time frame: 6 months

    Change in 24-hour ambulatory blood pressure from baseline to 6 months

  3. Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)

    Time frame: 6 months

    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.

  4. Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)

    Time frame: 6 months

    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).

  5. Patient satisfaction with sleep testing

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark I Boulos, MD, MSc

CONTACT

[email protected]

4164804473

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Women's College Hospital

Registry information

Acronym: SUPER-SHARP

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 26, 2023
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.