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Trial Outcomes & Findings for Temperature Manipulating Gloves for the Treatment of Insomnia (NCT NCT02341287)

NCT ID: NCT02341287

Last Updated: 2022-10-04

Results Overview

The Outcome Measure will be assessed via actigraphy monitoring. Sleep latency will be measured on the actigraphy monitoring device and measured twice; during a two-week control period (non-thermal glove) and during the two-week treatment period (thermal hydrogel glove).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

2 weeks for each condition

Results posted on

2022-10-04

Participant Flow

The study utilizes a crossover design. Therefore, each subject is in both control and treatment groups.

Participant milestones

Participant milestones
Measure
Non-thermal Glove, Then Warming Hydrogel Glove
In the first two-week period, subjects will wear a non-thermal glove. In the second two-week period, subjects will wear a warming hydrogel glove. Also an actigraph to monitor sleep latency.
Warming Hydrogel Glove, Then Non-thermal Glove
In the first two-week period, subjects will wear a warming hydrogel glove. In the second two-week period, subjects will wear a non-thermal glove. Also a actigraph to monitor sleep latency.
1st Intervention (2 Weeks)
STARTED
7
6
1st Intervention (2 Weeks)
COMPLETED
7
6
1st Intervention (2 Weeks)
NOT COMPLETED
0
0
2nd Intervention (2 Weeks)
STARTED
7
6
2nd Intervention (2 Weeks)
COMPLETED
7
6
2nd Intervention (2 Weeks)
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Temperature Manipulating Gloves for the Treatment of Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Non-thermal Glove, Then Warming Hydrogel Glove
n=7 Participants
In the first two-week period, subjects will wear a non-thermal glove. In the second two-week period, subjects will wear a warming hydrogel glove.
Warming Hydrogel Glove, Then Non-thermal Glove
n=6 Participants
In the first two-week period, subjects will wear a warming hydrogel glove. In the second two-week period, subjects will wear a non-thermal glove.
Total
n=13 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=99 Participants
6 Participants
n=107 Participants
13 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
4 Participants
n=99 Participants
3 Participants
n=107 Participants
7 Participants
n=206 Participants
Sex: Female, Male
Male
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Region of Enrollment
United States
7 participants
n=99 Participants
6 participants
n=107 Participants
13 participants
n=206 Participants

PRIMARY outcome

Timeframe: 2 weeks for each condition

The Outcome Measure will be assessed via actigraphy monitoring. Sleep latency will be measured on the actigraphy monitoring device and measured twice; during a two-week control period (non-thermal glove) and during the two-week treatment period (thermal hydrogel glove).

Outcome measures

Outcome measures
Measure
Non-thermal Glove
n=13 Participants
Subjects wore the non-thermal glove in either the first or second two-week period.
Warming Hydrogel Glove
n=13 Participants
Subjects wore the warming hydrogel glove in either the first or second two-week period.
Sleep Latency Assessed Via Actigraphy Monitoring
58.40 Minutes
Standard Deviation 25.29
44.39 Minutes
Standard Deviation 21.23

SECONDARY outcome

Timeframe: 2-weeks

Sleep latency measured in minutes via subjective sleep log.

Outcome measures

Outcome measures
Measure
Non-thermal Glove
n=13 Participants
Subjects wore the non-thermal glove in either the first or second two-week period.
Warming Hydrogel Glove
n=13 Participants
Subjects wore the warming hydrogel glove in either the first or second two-week period.
Sleep Latency Assessed Via Sleep Log.
56.36 Minutes
Standard Deviation 23.56
42.84 Minutes
Standard Deviation 23.60

Adverse Events

Non-thermal Glove

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Warming Hydrogel Glove

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

Matthew R. Ebben, Ph.D.

Weill Cornell Medicine

Phone: 646-962-9313

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place