Trial Outcomes & Findings for Frequen-ZZZ SleepPad Investigational Device POC (NCT NCT05908344)

Last Updated: 2024-12-16

Results Overview

Quantity of each sleep stage defined by the American Academy of Sleep Medicine (NREM1, NREM2, NREM3, and REM), measured by clinically standard elements of Polysomnography and scored by a Registered Polysomnographic Technologist. Note: Randomization to Active or Sham during Phase 1 or Phase 2 occurred at the end of Baseline week.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

The later viable night of two recordings: At the end of Phase 1 - Week 2 or Phase 1 - Week 3, and At the end of Phase 2 - Week 2 or Phase 2 - Week 3. Sleep stage minutes (relative to Latency to Persistent Sleep, Edinger et al. 2013).

Results posted on

2024-12-16

Participant Flow

Convenience sample of 40-65y/o with evidence of Insomnia symptoms in the State College, PA region.

Demonstrated adherence to study procedures (surveys \& actigraphy worn) during Baseline (Wk 1)

Participant milestones

Participant milestones
Measure	Active Device in Phase 1, Then Sham Device in Phase 2 Wks 2-5 Active Device, Wks 6-8 Sham Device	Sham Device in Phase 1, Then Active Device in Phase 2 Wks 2-5 Sham Device, Wks 6-8 Active Device
Overall Study STARTED	5	5
Overall Study Started Phase 1	5	5
Overall Study Started Phase 2	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Frequen-ZZZ SleepPad Investigational Device POC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Device Phase 1, Then Sham Device Phase 2 n=5 Participants Wks 2-5 Active Device, then Wks 6-8 Sham Device	Sham Device Phase 1, Then Active Device Phase 2 n=5 Participants Wks 2-5 Sham Device, then Wks 6-8 Active Device	Total n=10 Participants Total of all reporting groups
Age, Continuous	55.4 Years STANDARD_DEVIATION 3.2 • n=5 Participants	55.1 Years STANDARD_DEVIATION 8.5 • n=7 Participants	55.2 Years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Insomnia Severity Index (ISI)	9.6 Overall sum score STANDARD_DEVIATION 5.2 • n=5 Participants	12.4 Overall sum score STANDARD_DEVIATION 3.3 • n=7 Participants	11.0 Overall sum score STANDARD_DEVIATION 4.3 • n=5 Participants
Non-Rapid Eye Movement Stage 1 (NREM1) minutes	61.6 Minutes STANDARD_DEVIATION 16.1 • n=5 Participants	92.3 Minutes STANDARD_DEVIATION 61.9 • n=7 Participants	77.0 Minutes STANDARD_DEVIATION 45.6 • n=5 Participants
Non-Rapid Eye Movement Stage 1 (NREM1) percentage	17.0 % of Total Sleep STANDARD_DEVIATION 5.8 • n=5 Participants	21.7 % of Total Sleep STANDARD_DEVIATION 13.3 • n=7 Participants	19.4 % of Total Sleep STANDARD_DEVIATION 10.0 • n=5 Participants
Non-Rapid Eye Movement Stage 2 (NREM2) minutes	190.2 Minutes STANDARD_DEVIATION 56.2 • n=5 Participants	193.5 Minutes STANDARD_DEVIATION 20.9 • n=7 Participants	191.9 Minutes STANDARD_DEVIATION 40.0 • n=5 Participants
Non-Rapid Eye Movement Stage 2 (NREM2) percentage	49.9 % of Total Sleep STANDARD_DEVIATION 8.5 • n=5 Participants	47.4 % of Total Sleep STANDARD_DEVIATION 8.3 • n=7 Participants	48.7 % of Total Sleep STANDARD_DEVIATION 8.1 • n=5 Participants
Non-Rapid Eye Movement Stage 3 (NREM3) minutes	20.2 Minutes STANDARD_DEVIATION 22.2 • n=5 Participants	29.1 Minutes STANDARD_DEVIATION 30.9 • n=7 Participants	24.7 Minutes STANDARD_DEVIATION 25.8 • n=5 Participants
Non-Rapid Eye Movement Stage 3 (NREM3) percentage	5.2 % of Total Sleep STANDARD_DEVIATION 5.4 • n=5 Participants	7.2 % of Total Sleep STANDARD_DEVIATION 7.5 • n=7 Participants	6.21 % of Total Sleep STANDARD_DEVIATION 6.26 • n=5 Participants
Rapid Eye Movement (REM) minutes	102.9 Minutes STANDARD_DEVIATION 17.6 • n=5 Participants	98.0 Minutes STANDARD_DEVIATION 23.2 • n=7 Participants	100.5 Minutes STANDARD_DEVIATION 19.6 • n=5 Participants
Rapid Eye Movement (REM) percentage	27.9 % of Total Sleep STANDARD_DEVIATION 6.0 • n=5 Participants	23.7 % of Total Sleep STANDARD_DEVIATION 4.7 • n=7 Participants	25.8 % of Total Sleep STANDARD_DEVIATION 5.5 • n=5 Participants

PRIMARY outcome

Timeframe: The later viable night of two recordings: At the end of Phase 1 - Week 2 or Phase 1 - Week 3, and At the end of Phase 2 - Week 2 or Phase 2 - Week 3. Sleep stage minutes (relative to Latency to Persistent Sleep, Edinger et al. 2013).

Population: The same 10 (total) participants are represented in Arm/Group (repeated-measures).

Outcome measures

Outcome measures
Measure	Active Device n=10 Participants 3wks (either study wks 2-4 in an 'Active' Phase 1 or wks 6-8 in an 'Active' Phase 2), Active bedside controller.	Sham Device n=10 Participants 3wks (either study wks 2-4 in a 'Sham' Phase 1 or wks 6-8 in a 'Sham' Phase 2), Sham bedside controller.
Change in Sleep Architecture NREM1	48.8 Minutes Standard Deviation 23.5	54.0 Minutes Standard Deviation 36.4
Change in Sleep Architecture NREM2	212.5 Minutes Standard Deviation 37.8	218.7 Minutes Standard Deviation 40.5
Change in Sleep Architecture NREM3	32.85 Minutes Standard Deviation 25.8	22.85 Minutes Standard Deviation 17.0
Change in Sleep Architecture REM	88.5 Minutes Standard Deviation 32.7	108.9 Minutes Standard Deviation 38.6

PRIMARY outcome

Timeframe: The later viable night of two recordings: At the end of Phase 1 - Week 2 or Phase 1 - Week 3, and At the end of Phase 2 - Week 2 or Phase 2 - Week 3. Sleep stage percentage (relative to Latency to Persistent Sleep, Edinger et al. 2013).

Population: The same 10 (total) participants are represented in Arm/Group (repeated-measures)

Percentage of each sleep stage defined by the American Academy of Sleep Medicine (NREM1, NREM2, NREM3, and REM), measured by clinically standard elements of Polysomnography and scored by a Registered Polysomnographic Technologist. Note: Randomization to Active or Sham during Phase 1 or Phase 2 occurred at the end of Baseline week.

Outcome measures

Outcome measures
Measure	Active Device n=10 Participants 3wks (either study wks 2-4 in an 'Active' Phase 1 or wks 6-8 in an 'Active' Phase 2), Active bedside controller.	Sham Device n=10 Participants 3wks (either study wks 2-4 in a 'Sham' Phase 1 or wks 6-8 in a 'Sham' Phase 2), Sham bedside controller.
Change in Sleep Architecture NREM1	12.8 % of total sleep Standard Deviation 6.7	13.0 % of total sleep Standard Deviation 7.2
Change in Sleep Architecture NREM2	55.5 % of total sleep Standard Deviation 6.8	54.3 % of total sleep Standard Deviation 9.5
Change in Sleep Architecture NREM3	9.0 % of total sleep Standard Deviation 7.4	5.9 % of total sleep Standard Deviation 4.5
Change in Sleep Architecture REM	22.6 % of total sleep Standard Deviation 6.3	26.8 % of total sleep Standard Deviation 9.6

PRIMARY outcome

Timeframe: Sum ISI score near end of Phase 1 (study wks2-4) and near end of Phase 2 (study wks6-8).

Population: In this repeated-measures design, one participant had missing data for an Insomnia Severity Index (ISI) measure. Therefore, the analyzed sample for ISI Outcome is n=9 (5 Active Device Phase 1, then Sham; + 4 Sham Device Phase 1, then Active), rather than n=10.

Self-reported score on the Insomnia Severity Index (ISI; 0-28) e-survey, where a higher score indicates worse/more Insomnia symptoms.

Outcome measures

Outcome measures
Measure	Active Device n=9 Participants 3wks (either study wks 2-4 in an 'Active' Phase 1 or wks 6-8 in an 'Active' Phase 2), Active bedside controller.	Sham Device n=9 Participants 3wks (either study wks 2-4 in a 'Sham' Phase 1 or wks 6-8 in a 'Sham' Phase 2), Sham bedside controller.
Change in Insomnia Symptoms	7.3 Sum score, on a scale of 0-28 Standard Deviation 4.4	6.8 Sum score, on a scale of 0-28 Standard Deviation 5.0

Adverse Events

Active Device

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sham Device

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active Device n=10 participants at risk 3wks (either study wks 2-4 in an 'Active' Phase 1 or wks 6-8 in an 'Active' Phase 2), Active bedside controller.	Sham Device n=10 participants at risk 3wks (either study wks 2-4 in a 'Sham' Phase 1 or wks 6-8 in a 'Sham' Phase 2), Sham bedside controller.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.	0.00% 0/10 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.
Renal and urinary disorders Bladder infection	10.0% 1/10 • Number of events 1 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.	0.00% 0/10 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.
Gastrointestinal disorders Stomach pain	0.00% 0/10 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.	10.0% 1/10 • Number of events 1 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.
Eye disorders Cornea tear	0.00% 0/10 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.	10.0% 1/10 • Number of events 1 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.
Musculoskeletal and connective tissue disorders Aching, Discomfort, or Pain (various)	30.0% 3/10 • Number of events 3 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.	10.0% 1/10 • Number of events 1 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.
Skin and subcutaneous tissue disorders Study watch discomfort	10.0% 1/10 • Number of events 1 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.	0.00% 0/10 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.
Gastrointestinal disorders Heartburn	0.00% 0/10 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.	10.0% 1/10 • Number of events 1 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.
Eye disorders Stye	0.00% 0/10 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.	10.0% 1/10 • Number of events 1 • Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024. The Adverse Event definition used in this research is the same as that used by clinicaltrials.gov. Adverse Event data were collected using a standard researcher-administered survey at study visits.

Additional Information

Dr. Anne-Marie Chang

The Pennsylvania State University

Phone: 814-863-5226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place