Sleep Apnea SyndromesPhase 4SLEEP-PARTNERSNCT03011294
Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea
A Phase 4 study testing Continuous positive airway pressure (CPAP) and Nasal strip in people with Sleep Apnea Syndromes, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact not limited to the patients but also to the partner that sleep in the same bed. Is it reasonable to speculate that the partner suffer sleep deprivation, increased level of irritability, insomnia, fatigue, among others due to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Continuous positive airway pressure (CPAP) and Nasal strip
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2018to 1 Jun 2024
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bed partners of patients with moderate to severe OSA
Who cannot join
- Bed partners with OSA using specific treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea: a Randomized Study
Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact not limited to the patients but also to the partner that sleep in the same bed. Is it reasonable to speculate that the partner suffer sleep deprivation, increased level of irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA patient. Although previous data reported impaired sleep quality in partners of patients with OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the improvements in the subjective and objective sleep. Thus, the main objectives of this randomized controlled study are: to evaluate the impact of three months of randomization (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of patients with moderate to severe OSA.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Continuous positive airway pressure (CPAP), Nasal strip
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP)Device
Standard treatment for sleep apnea
Nasal stripDevice
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CPAP (in the partner) | Active comparator | Positive airway pressure for treating OSA in the bed partner. Receives: Device: Continuous positive airway pressure (CPAP) |
| Nasal strips (in the partner) | Placebo comparator | Nasal dilator as a placebo for treating OSA in the bed partner. Receives: Device: Nasal strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function (forearm dilation, FMD - %)
Measured: 3 months
Secondary outcomes (4)
Sleep quantity (measured by actigraphy - hours/night)
1 week of wrist actigraphy
Measured: 3 months
Sleep quality (Pittsburgh Questionnaire)
Measured: 3 months
Ambulatory blood pressure monitoring (ABPM)
Measured: 3 months
Frequency of OSA
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start1 Dec 2018
- Primary completion30 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciano F Drager, MD, PhD, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011294
- Sponsor's protocol ID
- SDC 4165.14.145
- Acronym
- SLEEP-PARTNERS
- Status last verified
- Jun 2024
- First submitted
- 27 Dec 2016
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giampa SQC, Furlan SF, Macedo TA, Cruz FC, Cabrini ML, de Barros S, Azam IF, Costa-Hong VA, Fernandes PH, Bortolotto LA, Lorenzi-Filho G, Drager LF. Effects of obstructive sleep apnoea treatment on cardiovascular and sleep health in bed partners: the sleep partners clinical trial. Thorax. 2026 Sep 22:thorax-2026-225271. doi: 10.1136/thorax-2026-225271. Online ahead of print.
PubMed 42772900
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea: a Randomized Study
- ClinicalTrials.gov ID
- NCT03011294
- Acronym / sponsor ID
- SLEEP-PARTNERS / SDC 4165.14.145
- Conditions
- Sleep Apnea Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 Jan 2017 (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.
Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact not limited to the patients but also to the partner that sleep in the same bed. Is it reasonable to speculate that the partner suffer sleep deprivation, increased level of irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA patient. Although previous data reported impaired sleep quality in partners of patients with OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the improvements in the subjective and objective sleep. Thus, the main objectives of this randomized controlled study are: to evaluate the impact of three months of randomization (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of patients with moderate to severe OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP (in the partner) | Active comparator | Device: Continuous positive airway pressure (CPAP)Positive airway pressure for treating OSA in the bed partner. |
| Nasal strips (in the partner) | Placebo comparator | Device: Nasal stripNasal dilator as a placebo for treating OSA in the bed partner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bed partners of patients with moderate to severe OSA
Key exclusion criteria (1 listed)
- Bed partners with OSA using specific 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 |
|---|---|---|
| Continuous positive airway pressure (CPAP)Standard treatment for sleep apnea | Device | CPAP (in the partner) |
| Nasal stripPlacebo | Device | Nasal strips (in the partner) |
Primary outcome
Endothelial function (forearm dilation, FMD - %)
Time frame: 3 months
4 secondary outcomes
Sleep quantity (measured by actigraphy - hours/night)
Time frame: 3 months
Sleep quality (Pittsburgh Questionnaire)
Time frame: 3 months
Ambulatory blood pressure monitoring (ABPM)
Time frame: 3 months
Frequency of OSA
Time frame: Baseline only
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 10 Jun 2024.
- Derived from this study: PubMed 42772900Giampa SQC, Furlan SF, Macedo TA, Cruz FC, Cabrini ML, de Barros S, Azam IF, Costa-Hong VA, Fernandes PH, Bortolotto LA, Lorenzi-Filho G, Drager LF. Effects of obstructive sleep apnoea treatment on cardiovascular and sleep health in bed partners: the sleep partners clinical trial. Thorax. 2026 Sep 22:thorax-2026-225271. doi: 10.1136/thorax-2026-225271. Online ahead of print.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Continuous positive airway pressure (CPAP) and Nasal strip in people with Sleep Apnea Syndromes, run by University of Sao Paulo 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 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 10 Jun 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Endothelial function (forearm dilation, FMD - %) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011294, which also lists 1 linked publication.
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 10 Jun 2024.