Sleep Apnea, ObstructiveNCT02451241
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension
A study testing acupuncture in people with Sleep Apnea, Obstructive, run by University of Pernambuco at 1 site in Brazil.
Trial summary
Recent evidences from small studies show potential benefit of acupuncture in the treatment of obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on the cardiovascular system. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Mar 2016
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 5<apnea-hypopnea index (AHI)<30 e/h
Who cannot join
- body mass index > 35 kg/m2
- Previous OSA treatment
Trial locations and contacts
1 site in 1 country.
About this study
Recent evidences from small studies show potential benefit of acupuncture in the treatment of obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on the cardiovascular system.
Primary end-point:
To investigate the effects of acupuncture in improving OSA severity among hypertensive patients.
Secondary end-point To investigate the effect of acupuncture in improving the quality of life and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- acupuncture
- Keywords
- Acupuncture
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
electroacupuncture
| Study group | Role | What they receive |
|---|---|---|
| sham acupuncture | Sham comparator | group will be submitted to placebo electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min. Receives: Other: acupuncture |
| acupuncture | Experimental | group will be submitted to electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min. Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI)
reduction in AHI
Measured: 5 weeks
Secondary outcomes (4)
Sleep quality
Improvement in PSQI scores
Measured: 5 weeks
Pulse Wave Velocity (PWV)
reduction in PWV
Measured: 5 weeks
Blood pressure
ambulatory blood pressure monitoring (ABPM) 24h reduction
Measured: 5 weeks
Quality of life
Short Form 36 Health Survey (SF36) scores
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Pinto Pedrosa, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451241
- Sponsor's protocol ID
- sleep01
- Status last verified
- May 2017
- First submitted
- 19 May 2015
- Last updated
- 3 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT02451241
- Acronym / sponsor ID
- sleep01
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 May 2015 (estimated)
- 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.
Recent evidences from small studies show potential benefit of acupuncture in the treatment of obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on the cardiovascular system.
Primary end-point:
To investigate the effects of acupuncture in improving OSA severity among hypertensive patients.
Secondary end-point To investigate the effect of acupuncture in improving the quality of life and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham acupuncture | Sham comparator | Other: acupuncturegroup will be submitted to placebo electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min. |
| acupuncture | Experimental | Other: acupuncturegroup will be submitted to electroacupuncture for 20 minutes, two times a week for 5 weeks. Each session lasts about 40 min. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 5<apnea-hypopnea index (AHI)<30 e/h
Key exclusion criteria (2 listed)
- body mass index > 35 kg/m2
- Previous OSA treatment
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 |
|---|---|---|
| acupunctureelectroacupuncture | Other | acupuncture, sham acupuncture |
Primary outcome
Apnea-hypopnea index (AHI)
Time frame: 5 weeks
reduction in AHI
4 secondary outcomes
Sleep quality
Time frame: 5 weeks
Pulse Wave Velocity (PWV)
Time frame: 5 weeks
Blood pressure
Time frame: 5 weeks
Quality of life
Time frame: 5 weeks
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 3 May 2017.
Related trials for Sleep Apnea, Obstructive
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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?
A study testing acupuncture in people with Sleep Apnea, Obstructive, run by University of Pernambuco at 1 site in Brazil.
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 2 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 3 May 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Apnea-hypopnea index (AHI) (time frame: 5 weeks). 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 3 May 2017.