Healthy VolunteersCPAP_normalNCT02545686
Effect of CPAP on Breath Hold and Chest Movement in Normal Volunteers
A study testing Chest wall movement assessment without CPAP, Breath hold assessment without CPAP and Chest wall movement assessment with CPAP in people with Healthy Volunteers and Effect of CPAP on Chest Movement, run by Sheba Medical Center at 1 site in Israel.
Trial summary
CPAP will be applied to normal volunteers inorder to understand CPAP's effects on breathing and chest wall motion. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Effect of CPAP on Chest Movement
- What is being tested?
- Chest wall movement assessment without CPAP, Breath hold assessment without CPAP and Chest wall movement assessment with CPAP
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Sep 2019
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal volunteers without a cancer diagnosis.
- No contraindications to the use of CPAP
- Facial injury or deformity preventing wearing facial mask
- Recurrent vomiting
- Chronic cough with phlegm
- Previous pneumothorax
Show all 12Show fewer
- Facial lacerations or fractures
- Recent tracheal or esophageal anastomosis
- Recent GI surgery (last 90 days).
- 18-90 years of age
- Ability to sign informed consent
- Hebrew or English speakers
Who cannot join
- Contraindications to CPAP
- Facial injury or deformity preventing wearing facial mask
- Recurrent vomiting
- Chronic cough with phlegm
- Previous pneumothorax
- Facial lacerations or fractures
Show all 13Show fewer
- Recent tracheal or esophageal anastomosis
- Recent GI surgery (last 90 days).
- Under age 18 or above age 90 years
- Inability to sign informed consent
- Members of special populations (mental illness, pregnant women, prisoners, not legally competent).
- History of severe active restrictive or obstructive lung disease (as defined as at least one hospitalization over previous two years)
- Any medical condition requiring an inpatient hospitalization for more than 72 hours over the previous 2 years, aside from elective surgery.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Yaacov R Lawrence, MBBS MA MRCP, 97235304410, Yaacov.Lawrence@sheba.health.gov.il
Hila Gnessin, 035307034, Hila.Gnessin@sheba.health.gov.il
About this study
Official title: Use of the Real-time Position Management (RPM) to Measure the Effects of Continuous Positive Airway Pressure (CPAP) on Duration of Breath Hold and Diaphragm Motion in Normal Volunteers
CPAP will be applied to normal volunteers inorder to understand CPAP's effects on breathing and chest wall motion.
Read the detailed description
CPAP is a non-invasive ventilation technique that is commonly used to treat sleep apnea. Using a small air-pump, tubing and facemask, it provides a constant stream of pressurized air to the upper airways and lungs. Some of the physiological effects noted during CPAP are hyperinflation of the lungs, stabilizing and flattening of the diaphragm, and decrease in tidal volume. The effects on duration of breath hold are unknown. During radiation treatment, these effects are expected to reduce tumor and organ motion which reduces the volume of normal tissue being irradiated and also creates favorable treatment geometry by moving the heart away from the anterior chest wall. An important advantage of CPAP compared to other techniques is that active patient cooperation is not required. The potential exists to combine use of CPAP with other respiratory management techniques such as breath hold and improve overall effectiveness. When used in sleep apnea it is well tolerated and poses little risk to patients. There are no published reports of the use of CPAP in radiation therapy.
In initial studies the Varian RPM system was used to assess respiratory motion with and without CPAP for patients receiving radiation therapy. This commercially available, non-invasive system works by directing an infrared beam onto an infrared motion detector that is placed on the patients' upper abdomen. The detector records the change in abdomen position that occurs with respiration as a change in amplitude of the detector position. Interventions that effect respiration will be recorded by an increase or decrease in the amplitude of the detector motion. When used in breath hold, the detector remains in a fixed position with a very narrow gating window.
Based on initial experience with the RPM system, it has been found that approximately 1 hour of CPAP use is required to reduce diaphragm motion. Although early results are favorable using this approach, it is not certain that this is the best or most efficient method of use for all patients. The use of CPAP combined with breath hold techniques has not been studied.
The objectives of this study are to use the RPM system in normal volunteers to:
- Study the effects of CPAP on diaphragm motion to allow better optimization for the use of CPAP as a respiratory management technique during free breathing.
- Determine the feasibility of use of CPAP as a respiratory aid for use in patients treated with breath hold techniques. Determine the effects of CPAP on duration; reproducibility and tolerance of the breath hold technique.
- Being tested
- Chest wall movement assessment without CPAP, Breath hold assessment without CPAP, Chest wall movement assessment with CPAP, Breath hold assessment with CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest wall movement assessment without CPAPBehavioural
While subject is breathing normally, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.
Breath hold assessment without CPAPBehavioural
While subject is breathing normally, subject will perform a moderate and a deep inspiratory breath hold. Duration, reproducibility and tolerance of deep inspiratory breath hold will be recorded.
Chest wall movement assessment with CPAPProcedure or surgery
While subject is breathing via CPAP machine, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.
Breath hold assessment with CPAPProcedure or surgery
While subject is breathing via CPAP machine, subject will perform a moderate and a deep inspiratory breath hold. Duration, reproducibility and tolerance of deep inspiratory breath hold will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| one | Experimental | this is a single arm study. All subjects treated the same way, and undergo four interventions:
1. Chest wall movement assessment without CPAP
2. Breath hold assessment without CPAP
3. Chest wall movement assessment with CPAP
4. Breath hold assessment with CPAP Receives: Behavioral: Chest wall movement assessment without CPAP; Behavioral: Breath hold assessment without CPAP; Procedure: Chest wall movement assessment with CPAP; Procedure: Breath hold assessment with CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest wall motion amplitude
Amplitude of chest wall motion, measured in centimeters.
Measured: 2 hours
Secondary outcomes (3)
Duration of breath hold
Length (in seconds) that are subjects able to hold their breath.
Measured: 2 hours
Reproducibility of breath hold depth
When 'breath hold' is performed three consecutive times, ascertain if it performed to the same depth each time. Measured in centimeters.
Measured: 2 hours
Respiratory rate
Number of breaths per minute.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jeffrey Goldstein, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545686
- Sponsor's protocol ID
- SHEBA-15-2364-YL-CTIL
- Acronym
- CPAP_normal
- Status last verified
- Oct 2017
- First submitted
- 2 Sep 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Real-time Position Management (RPM) to Measure the Effects of Continuous Positive Airway Pressure (CPAP) on Duration of Breath Hold and Diaphragm Motion in Normal Volunteers
- ClinicalTrials.gov ID
- NCT02545686
- Acronym / sponsor ID
- CPAP_normal / SHEBA-15-2364-YL-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 10 Sep 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.
CPAP will be applied to normal volunteers inorder to understand CPAP's effects on breathing and chest wall motion.
Detailed description
CPAP is a non-invasive ventilation technique that is commonly used to treat sleep apnea. Using a small air-pump, tubing and facemask, it provides a constant stream of pressurized air to the upper airways and lungs. Some of the physiological effects noted during CPAP are hyperinflation of the lungs, stabilizing and flattening of the diaphragm, and decrease in tidal volume. The effects on duration of breath hold are unknown. During radiation treatment, these effects are expected to reduce tumor and organ motion which reduces the volume of normal tissue being irradiated and also creates favorable treatment geometry by moving the heart away from the anterior chest wall. An important advantage of CPAP compared to other techniques is that active patient cooperation is not required. The potential exists to combine use of CPAP with other respiratory management techniques such as breath hold and improve overall effectiveness. When used in sleep apnea it is well tolerated and poses little risk to patients. There are no published reports of the use of CPAP in radiation therapy.
In initial studies the Varian RPM system was used to assess respiratory motion with and without CPAP for patients receiving radiation therapy. This commercially available, non-invasive system works by directing an infrared beam onto an infrared motion detector that is placed on the patients' upper abdomen. The detector records the change in abdomen position that occurs with respiration as a change in amplitude of the detector position. Interventions that effect respiration will be recorded by an increase or decrease in the amplitude of the detector motion. When used in breath hold, the detector remains in a fixed position with a very narrow gating window.
Based on initial experience with the RPM system, it has been found that approximately 1 hour of CPAP use is required to reduce diaphragm motion. Although early results are favorable using this approach, it is not certain that this is the best or most efficient method of use for all patients. The use of CPAP combined with breath hold techniques has not been studied.
The objectives of this study are to use the RPM system in normal volunteers to:
- Study the effects of CPAP on diaphragm motion to allow better optimization for the use of CPAP as a respiratory management technique during free breathing.
- Determine the feasibility of use of CPAP as a respiratory aid for use in patients treated with breath hold techniques. Determine the effects of CPAP on duration; reproducibility and tolerance of the breath hold technique.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one | Experimental | Behavioral: Chest wall movement assessment without CPAP, Behavioral: Breath hold assessment without CPAP, Procedure: Chest wall movement assessment with CPAP, Procedure: Breath hold assessment with CPAPthis is a single arm study. All subjects treated the same way, and undergo four interventions: 1. Chest wall movement assessment without CPAP 2. Breath hold assessment without CPAP 3. Chest wall movement assessment with CPAP 4. Breath hold assessment with CPAP |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Normal volunteers without a cancer diagnosis.
- No contraindications to the use of CPAP
- 18-90 years of age
- Ability to sign informed consent
- Hebrew or English speakers
Key exclusion criteria (13 listed)
- Contraindications to CPAP
- Under age 18 or above age 90 years
- Inability to sign informed consent
- Members of special populations (mental illness, pregnant women, prisoners, not legally competent).
- History of severe active restrictive or obstructive lung disease (as defined as at least one hospitalization over previous two years)
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 |
|---|---|---|
| Chest wall movement assessment without CPAPWhile subject is breathing normally, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour. | Behavioural | one |
| Breath hold assessment without CPAPWhile subject is breathing normally, subject will perform a moderate and a deep inspiratory breath hold. Duration, reproducibility and tolerance of deep inspiratory breath hold will be recorded. | Behavioural | one |
| Chest wall movement assessment with CPAPWhile subject is breathing via CPAP machine, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour. | Procedure or surgery | one |
| Breath hold assessment with CPAPWhile subject is breathing via CPAP machine, subject will perform a moderate and a deep inspiratory breath hold. Duration, reproducibility and tolerance of deep inspiratory breath hold will be recorded. | Procedure or surgery | one |
Primary outcome
Chest wall motion amplitude
Time frame: 2 hours
Amplitude of chest wall motion, measured in centimeters.
3 secondary outcomes
Duration of breath hold
Time frame: 2 hours
Reproducibility of breath hold depth
Time frame: 2 hours
Respiratory rate
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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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.
Jeffrey Goldstein, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest wall movement assessment without CPAP, Breath hold assessment without CPAP and Chest wall movement assessment with CPAP in people with Healthy Volunteers and Effect of CPAP on Chest Movement, run by Sheba Medical Center at 1 site in Israel.
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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 27 Oct 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hila Gnessin (972-3-5307340, Hila.Gnessin@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest wall motion amplitude (time frame: 2 hours). 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 27 Oct 2017.