The Effects of Obstructive Sleep Apnea on Blood Pressure MeasurementNCT06027424
Blood Pressure and Obstructive Sleep Apnea
An observational study of The Effects of Obstructive Sleep Apnea on Blood Pressure Measurement, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Bidirectional and causal relationship exists between obstructive sleep apnea (OSA) and hypertension in a dose-response manner, independent of confounding variables such as age, smoking, and body mass index. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Effects of Obstructive Sleep Apnea on Blood Pressure Measurement
- How many people
- 2,037 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Oct 2022to 16 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence
Who may be able to join
- (1). Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence; (2). Feasibility to measure BP via wrist monitors; (3). Confirmation of wakefulness through electroencephalography.
Who cannot join
- (1). Failure to measure BP via wrist monitors; (2). Age younger than 18 years; (3). Sleep efficiency less than 50%; (4). Central sleep apnea ≥ 50%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Changes in Blood Pressure in Patients With Obstructive Sleep Apnea Following an Overnight Sleep
Bidirectional and causal relationship exists between obstructive sleep apnea (OSA) and hypertension in a dose-response manner, independent of confounding variables such as age, smoking, and body mass index. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). The relationship between AHI and changes of blood pressure deserves further investigation.
Read the detailed description
Approximately 50% of patients with obstructive sleep apnea (OSA) have hypertension; up to 30% of patients with hypertension have OSA, and the prevalence is even higher in those of resistant hypertension. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). This retrospective study aimed to determine if OSA severity and AHI have effect on blood pressure measurements and the nocturnal changes following an overnight sleep.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Non-OSA | AHI < 5 events/h (AHI, apnea-hypopnea index, the number of apneas and hypopneas per hour of total sleep time) | |
| Mild OSA | 5 events/h ≤ AHI < 15 events/h | |
| Moderate OSA | 15 events/h ≤ AHI < 30 events/h | |
| Severe OSA | AHI ≥ 30 events/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure, before sleep and after awakening
Measurement of blood pressure at two time points: before sleep and after awakening
Measured: 20:30 pm ~ 06:00 am next day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start26 Oct 2022
- Primary completion28 Feb 2023
- Study completion16 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effects of Obstructive Sleep Apnea on Blood Pressure MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027424
- Sponsor's protocol ID
- 2022-07-013CC
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes in Blood Pressure in Patients With Obstructive Sleep Apnea Following an Overnight Sleep
- ClinicalTrials.gov ID
- NCT06027424
- Acronym / sponsor ID
- 2022-07-013CC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,037 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 16 Jul 2023 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bidirectional and causal relationship exists between obstructive sleep apnea (OSA) and hypertension in a dose-response manner, independent of confounding variables such as age, smoking, and body mass index. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). The relationship between AHI and changes of blood pressure deserves further investigation.
Detailed description
Approximately 50% of patients with obstructive sleep apnea (OSA) have hypertension; up to 30% of patients with hypertension have OSA, and the prevalence is even higher in those of resistant hypertension. OSA is conventionally diagnosed and graded by apnea-hypopnea index (AHI). This retrospective study aimed to determine if OSA severity and AHI have effect on blood pressure measurements and the nocturnal changes following an overnight sleep.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-OSA | – | –AHI < 5 events/h (AHI, apnea-hypopnea index, the number of apneas and hypopneas per hour of total sleep time) |
| Mild OSA | – | –5 events/h ≤ AHI < 15 events/h |
| Moderate OSA | – | –15 events/h ≤ AHI < 30 events/h |
| Severe OSA | – | –AHI ≥ 30 events/h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence
Key inclusion criteria (1 listed)
- (1). Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to obstructive sleep apnea, such as snoring and daytime somnolence; (2). Feasibility to measure BP via wrist monitors; (3). Confirmation of wakefulness through electroencephalography.
Key exclusion criteria (1 listed)
- (1). Failure to measure BP via wrist monitors; (2). Age younger than 18 years; (3). Sleep efficiency less than 50%; (4). Central sleep apnea ≥ 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational study, no intervention | Other | Mild OSA, Moderate OSA, Non-OSA, Severe OSA |
Primary outcome
Blood pressure, before sleep and after awakening
Time frame: 20:30 pm ~ 06:00 am next day
Measurement of blood pressure at two time points: before sleep and after awakening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Effects of Obstructive Sleep Apnea on Blood Pressure Measurement, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure, before sleep and after awakening (time frame: 20:30 pm ~ 06:00 am next day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.