Obstructive Sleep ApneaNCT02474823
Neck Grasp as a Predictor of Sleep Apnea
A study testing polysomnogram, home sleep test and Easy Sleep Apnea Predictor in people with Obstructive Sleep Apnea and Type 2 Diabetes, run by Bassett Healthcare at 1 site in United States.
Trial summary
A previous pilot study on the use of self neck grasp, ESAP (Easy Sleep Apnea Predictor), showed a positive maneuver (unable to wrap hands completely around neck) to be 100% predictive of sleep apnea in a sleep clinic population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea, Type 2 Diabetes
- What is being tested?
- polysomnogram, home sleep test and Easy Sleep Apnea Predictor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 70 years old regardless of gender
- Confirmed diagnosis of Type 2 diabetes
Who cannot join
- Unstable Heart failure
- COPD
- Neuromuscular disease
- Mental disorders which would interfere with following directions
- Persons who are already diagnosed with OSA or persons who have been using CPAP or BiPAP
Trial locations and contacts
1 site in 1 country.
United States1 site
Bassett Healthcare Network
Cooperstown, New York, 13326
About this study
A previous pilot study on the use of self neck grasp, ESAP (Easy Sleep Apnea Predictor), showed a positive maneuver (unable to wrap hands completely around neck) to be 100% predictive of sleep apnea in a sleep clinic population. The investigators now would like to compare ESAP to other tests used to diagnose and screen for Sleep Apnea in type 2 diabetics. The tests will included Home Sleep Testing, sleep questionnaires Berlin and STOP-BANG and polysomnogram (PSG). Patients with type 2 diabetes in the Bassett Endocrine Clinic who are scheduled for a routine evaluation will be recruited to undergo; a Home Sleep Test along with two sleep questionnaires PSG. The screen test wil be compared to the results of the gold standard diagnostic test the PSG for their predictive value os OSA in the type 2 diabetic population.
Read the detailed description
The goal is to evaluate the ESAP study (simple neck grasp) as a predictor of Obstructive Sleep Apnea (OSA) in combination with, and in comparison to; Home Sleep Test ( HST), Berlin Sleep Questionnaire and STOP-BANG questionnaire. All predictors are being evaluated against the gold standard test, the polysomnogram (PSG).
OSA is the common disorder affecting 3-7% of the adult population. It has many negative health consequences such as; cardiovascular disease, diabetes, motor vehicle accidents and depression. Data from both epidemiological and clinical studies suggest that OSA is also independently associated with alterations in glucose metabolism and places patients at an increased risk of the development of type 2 diabetes It is often missed in a busy practice. This simple diagnostic tool may help us in identifying the patient at an earlier stage, thus also helping to prevent further complications in diabetic patients.
Participants will undergo 3 study visits/procedures:
Visit 1: Participants will be consented for the study, undergo the ESAP test, complete the Berlin Sleep Questionnaire \& STOP-BANG questionnaire, and provide medical history/demographic information.
Visit 2: Participants will undergo a PSG at the Bassett Sleep Lab.. Visit 3: The morning the PSG is completed, participants will be given the HST recorder and instructed in its use in order to complete the HST. Participants can then drop off the HST recorder at any Bassett Clinic and it will be returned to the Sleep Lab in Cooperstown.
The ESAP test, Berlin Sleep Questionnaire, and the STOP-BANG Questionnaire will be administered by a study coordinator, research nurse, and/or research assistant. The PSG and the HST will be read and evaluated by independent evaluators/physicians. These physicians will not have access to the ESAP or the questionnaire results prior to the evaluation of the PSG or HST.
If a participant has any test (except the ESAP test alone) that is indicative or suspicious for OSA, a study physician will review these results and advise them of any further follow up recommendations.
- Conditions
- Obstructive Sleep Apnea, Type 2 Diabetes
- Being tested
- polysomnogram, home sleep test, Easy Sleep Apnea Predictor
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnogramOther
Also called PSG
all participants will undergo PSG for assessment of OSA
home sleep testOther
Also called HST
all participants will undergo HST for assessment of OSA
Easy Sleep Apnea PredictorOther
Also called ESAP , self neck grasp
all participants will undergo ESAP for assessment of OSA
| Study group | Role | What they receive |
|---|---|---|
| Sleep Apnea assessment | Other | all participants are in the same arm \& undergo the same assessments: PSG, HST, ESAP Receives: Other: polysomnogram; Other: home sleep test; Other: Easy Sleep Apnea Predictor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of ESAP testing
The ESAP measures a participant's ability to wrap their own hands around their neck, touching thumb to thumb, middle finger to middle finger. A "positive" test (unable to reach around the neck with fingers) would be indicative of the presence of OSA.
Measured: 3 months
Secondary outcomes (2)
results of HST
Positive HST would indicate presence of OSA
Measured: 3 months
Result of PSG testing
Positive PSG would indicate presence of OSA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
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 Obstructive Sleep ApneaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassett Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Edmonds, MD, Bassett Healthcare
- Investigators
- lee edmonds, MD, Principal investigator, Bassett Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474823
- Sponsor's protocol ID
- 2012
- Status last verified
- Jan 2017
- First submitted
- 9 Jun 2015
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Edmonds PJ, Gunasekaran K, Edmonds LC. Neck Grasp Predicts Obstructive Sleep Apnea in Type 2 Diabetes Mellitus. Sleep Disord. 2019 Jul 1;2019:3184382. doi: 10.1155/2019/3184382. eCollection 2019.
PubMed 31355009
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Grasp as a Predictor of Sleep Apnea
- ClinicalTrials.gov ID
- NCT02474823
- Acronym / sponsor ID
- 2012
- Conditions
- Obstructive Sleep Apnea, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bassett HealthcareUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Jun 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.
A previous pilot study on the use of self neck grasp, ESAP (Easy Sleep Apnea Predictor), showed a positive maneuver (unable to wrap hands completely around neck) to be 100% predictive of sleep apnea in a sleep clinic population. The investigators now would like to compare ESAP to other tests used to diagnose and screen for Sleep Apnea in type 2 diabetics. The tests will included Home Sleep Testing, sleep questionnaires Berlin and STOP-BANG and polysomnogram (PSG). Patients with type 2 diabetes in the Bassett Endocrine Clinic who are scheduled for a routine evaluation will be recruited to undergo; a Home Sleep Test along with two sleep questionnaires PSG. The screen test wil be compared to the results of the gold standard diagnostic test the PSG for their predictive value os OSA in the type 2 diabetic population.
Detailed description
The goal is to evaluate the ESAP study (simple neck grasp) as a predictor of Obstructive Sleep Apnea (OSA) in combination with, and in comparison to; Home Sleep Test ( HST), Berlin Sleep Questionnaire and STOP-BANG questionnaire. All predictors are being evaluated against the gold standard test, the polysomnogram (PSG).
OSA is the common disorder affecting 3-7% of the adult population. It has many negative health consequences such as; cardiovascular disease, diabetes, motor vehicle accidents and depression. Data from both epidemiological and clinical studies suggest that OSA is also independently associated with alterations in glucose metabolism and places patients at an increased risk of the development of type 2 diabetes It is often missed in a busy practice. This simple diagnostic tool may help us in identifying the patient at an earlier stage, thus also helping to prevent further complications in diabetic patients.
Participants will undergo 3 study visits/procedures:
Visit 1: Participants will be consented for the study, undergo the ESAP test, complete the Berlin Sleep Questionnaire \& STOP-BANG questionnaire, and provide medical history/demographic information.
Visit 2: Participants will undergo a PSG at the Bassett Sleep Lab.. Visit 3: The morning the PSG is completed, participants will be given the HST recorder and instructed in its use in order to complete the HST. Participants can then drop off the HST recorder at any Bassett Clinic and it will be returned to the Sleep Lab in Cooperstown.
The ESAP test, Berlin Sleep Questionnaire, and the STOP-BANG Questionnaire will be administered by a study coordinator, research nurse, and/or research assistant. The PSG and the HST will be read and evaluated by independent evaluators/physicians. These physicians will not have access to the ESAP or the questionnaire results prior to the evaluation of the PSG or HST.
If a participant has any test (except the ESAP test alone) that is indicative or suspicious for OSA, a study physician will review these results and advise them of any further follow up recommendations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Apnea assessment | Other | Other: polysomnogram, Other: home sleep test, Other: Easy Sleep Apnea Predictorall participants are in the same arm \& undergo the same assessments: PSG, HST, ESAP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 - 70 years old regardless of gender
- Confirmed diagnosis of Type 2 diabetes
Key exclusion criteria (5 listed)
- Unstable Heart failure
- COPD
- Neuromuscular disease
- Mental disorders which would interfere with following directions
- Persons who are already diagnosed with OSA or persons who have been using CPAP or BiPAP
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 |
|---|---|---|
| polysomnogramAlso: PSGall participants will undergo PSG for assessment of OSA | Other | Sleep Apnea assessment |
| home sleep testAlso: HSTall participants will undergo HST for assessment of OSA | Other | Sleep Apnea assessment |
| Easy Sleep Apnea PredictorAlso: ESAP , self neck graspall participants will undergo ESAP for assessment of OSA | Other | Sleep Apnea assessment |
Primary outcome
Result of ESAP testing
Time frame: 3 months
The ESAP measures a participant's ability to wrap their own hands around their neck, touching thumb to thumb, middle finger to middle finger. A "positive" test (unable to reach around the neck with fingers) would be indicative of the presence of OSA.
2 secondary outcomes
results of HST
Time frame: 3 months
Result of PSG testing
Time frame: 3 months
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 18 Jan 2017.
- Derived from this study: PubMed 31355009Edmonds PJ, Gunasekaran K, Edmonds LC. Neck Grasp Predicts Obstructive Sleep Apnea in Type 2 Diabetes Mellitus. Sleep Disord. 2019 Jul 1;2019:3184382. doi: 10.1155/2019/3184382. eCollection 2019.
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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.
lee edmonds, MD principal investigator
Bassett Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polysomnogram, home sleep test and Easy Sleep Apnea Predictor in people with Obstructive Sleep Apnea and Type 2 Diabetes, run by Bassett Healthcare at 1 site in United States.
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 2 inclusion and 5 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 18 Jan 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 United States. 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?
Result of ESAP testing (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 NCT02474823, 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 18 Jan 2017.