Trial Outcomes & Findings for Apnea Hypopnea Index Severity Versus Head Position During Sleep (NCT NCT04086407)

Results Overview

Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of apnea hypopnea index (AHI) for the total time duration spent sleeping in each head position. The key measurement is the subjects' relative improvement in AHI with the head supine (45⁰ to 135⁰) as compared to non-supine (\<20⁰above the horizon)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

Results posted on

2020-06-30

Participant Flow

Participants were pre-screened in clinic and using previous sleep study results within a two year time period with a diagnosis of Obstructive Sleep Apnea

No enrolled participants were excluded

Participant milestones

Participant milestones
Measure	Forehead Sensor Recording Precision Head Pitch and Roll Angle During an overnight polysomnography, participants were coached by sleep research technologists to sleep with their head in positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions to show insensitivity to torso position. A custom interface was developed to maintain compatibility with specific bedside polysomnography recorder auxiliary inputs. Sleep epochs were considered those where the subject slept for at least 10 minutes. Each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. Dual-axis inclinometer attached to the subject's forehead with tape: This is the first clinical trial to address OSA symptom severity and snoring as a direct function of head pitch and roll
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Forehead Sensor Recording Precision Head Pitch and Roll Angle n=8 Participants During an overnight polysomnography, participants were coached by sleep research technologists to sleep with their head in positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. A custom interface was developed to maintain compatibility with specific bedside polysomnography recorder auxiliary inputs. Sleep epochs were considered those where the subject slept for at least 10 minutes. Each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. Dual-axis inclinometer attached to the subject's forehead with tape: This is the first clinical trial to address OSA symptom severity and snoring as a direct function of head pitch and roll.
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants
Sex: Female, Male Female	6 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=8 Participants
Region of Enrollment United States	8 Participants n=8 Participants

PRIMARY outcome

Timeframe: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of apnea hypopnea index (AHI) for the total time duration spent sleeping in each head position. The key measurement is the subjects' relative improvement in AHI with the head supine (45⁰ to 135⁰) as compared to non-supine (\<20⁰above the horizon)

Outcome measures

Outcome measures
Measure	Forehead Sensor Recording Precision Head Pitch and Roll Angle n=8 Participants During an overnight polysomnography, participants were coached by sleep research technologists to sleep with head positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead dual axis inclinometer sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. Sleep epochs were considered those where the subject slept for at least 10 minutes and each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. This is the first clinical trial to address Obstructive Sleep Apnea (OSA) symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity.
Number of Participants With Apnea Hypopnea Index (AHI) Severity Improvement	8 Participants

PRIMARY outcome

Timeframe: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of SpO2 desaturation for the total time duration spent sleeping in each head position. The key measurement is the subjects' relative improvement in SpO2 de-saturation with the head supine (45⁰ to 135⁰) as compared to non-supine (\<20⁰above the horizon)

Outcome measures

Outcome measures
Measure	Forehead Sensor Recording Precision Head Pitch and Roll Angle n=8 Participants During an overnight polysomnography, participants were coached by sleep research technologists to sleep with head positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead dual axis inclinometer sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. Sleep epochs were considered those where the subject slept for at least 10 minutes and each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. This is the first clinical trial to address Obstructive Sleep Apnea (OSA) symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity.
Number of Participants With SpO2 Desaturation Severity Improvement	8 Participants

PRIMARY outcome

Timeframe: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of apnea hypopnea index (AHI) as subjects sleep with the torso in the supine position while the head is ≤ 20⁰ and with the torso in the non-supine position while the head is above 45 degrees. The key measurement is the subjects' relative improvement in AHI with the head supine (45⁰ to 135⁰) as compared to non-supine (\<20⁰above the horizon) independent of torso position

Outcome measures

Outcome measures
Measure	Forehead Sensor Recording Precision Head Pitch and Roll Angle n=8 Participants During an overnight polysomnography, participants were coached by sleep research technologists to sleep with head positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead dual axis inclinometer sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. Sleep epochs were considered those where the subject slept for at least 10 minutes and each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. This is the first clinical trial to address Obstructive Sleep Apnea (OSA) symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity.
Number of Participants With Improvement Independent of Torso Using Forehead Mounted Pitch and Roll Angle Sensor	8 Participants

PRIMARY outcome

Timeframe: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch

Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of SpO2 desaturation as subjects sleep with the torso in the supine position while the head is ≤ 20⁰ and with the torso in the non-supine position while the head is above 45 degrees. The key measurement is the subjects' relative improvement in SpO2 desaturation with the head supine (45⁰ to 135⁰) as compared to non-supine (\<20⁰above the horizon) independent of torso position

Outcome measures

Outcome measures
Measure	Forehead Sensor Recording Precision Head Pitch and Roll Angle n=8 Participants During an overnight polysomnography, participants were coached by sleep research technologists to sleep with head positions hypothesized to minimize apnea severity ≤20⁰ or ≥160⁰, and those hypothesized to maximize apnea severity between 30⁰ and 150⁰. Head roll angles were measured and recorded by the participant's forehead dual axis inclinometer sensor attached with adhesive and tape. Extreme head positions were attempted with the torso in both supine and non-supine positions so show insensitivity to torso position. Sleep epochs were considered those where the subject slept for at least 10 minutes and each head position epoch was analyzed for apnea hypopnea index and oxygen desaturation. This is the first clinical trial to address Obstructive Sleep Apnea (OSA) symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity.
Torso Independent With SpO2 Improvement Using Forehead Mounted Pitch and Roll Angle Sensor	8 Participants

Adverse Events

Forehead Sensor Recording Precision Head Pitch and Roll Angle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Operations

Sleep Systems

Phone: 978-835-7036

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place