Trial Outcomes & Findings for A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes (NCT NCT03616171)

Last Updated: 2019-12-30

Results Overview

Feasibility of the study is assessed by number of enrollments in the study over a one year period. Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2019-12-30

Participant Flow

Participants were enrolled between August 30, 2017 and April 2, 2018 from Georgia State University in Atlanta, Georgia.

A total of 19 individuals consented to take part in the study, of which 13 did not meet eligibility criteria during the screening process, resulting in 6 participants who were randomized to a study arm.

Participant milestones

Participant milestones
Measure	SLEEP-Extend Intervention Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.	Control Group Participants receiving one educational session consisting of safety practices used for an urban environment.
Overall Study STARTED	4	2
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SLEEP-Extend Intervention n=4 Participants Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.	Control Group n=2 Participants Participants receiving one educational session consisting of safety practices used for an urban environment.	Total n=6 Participants Total of all reporting groups
Age, Continuous	19 years STANDARD_DEVIATION 0.82 • n=5 Participants	21.5 years STANDARD_DEVIATION 4.95 • n=7 Participants	19.83 years STANDARD_DEVIATION 2.64 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 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/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Persian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Marital Status Single	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Marital Status Married	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Marital Status Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Feasibility of the study is assessed by number of enrollments in the study over a one year period. Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.

Outcome measures

Outcome measures
Measure	SLEEP-Extend Intervention n=4 Participants Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.	Control Group n=2 Participants Participants receiving one educational session consisting of safety practices used for an urban environment.
Number of Enrollments in the Study Over One Year	4 Participants	2 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Only participants in the intervention arm are included in this analysis.

Feasibility of the SLEEP-Extend intervention among young adults is measured by number of participants enrolled in the intervention arm that received the intervention and completed the study required protocols for the study duration of 4 weeks.

Outcome measures

Outcome measures
Measure	SLEEP-Extend Intervention n=4 Participants Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.	Control Group Participants receiving one educational session consisting of safety practices used for an urban environment.
Number of Participants Enrolled in the Intervention Arm Who Complete the Study	4 Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 4

The HOMA-IR score is used to measure severity of insulin resistance, though normal insulin resistance varies depending on the population. HOMA-IR is calculated as blood glucose level (nmol/L) multiplied by insulin level (microU/L), divided by 22.5. Elevated values indicate insulin resistance. A cutoff score of HOMA-IR \< 2.1 is considered normal and HOMA-IR ≥ 2.1 is considered to be evidence of insulin resistance.

Outcome measures

Outcome measures
Measure	SLEEP-Extend Intervention n=4 Participants Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.	Control Group n=2 Participants Participants receiving one educational session consisting of safety practices used for an urban environment.
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores Baseline	5.73 HOMA-IR score Standard Deviation 3.81	4.33 HOMA-IR score Standard Deviation 0.94
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores Week 4	6.55 HOMA-IR score Standard Deviation 5.47	5.13 HOMA-IR score Standard Deviation 1.54

SECONDARY outcome

Timeframe: Over a 1 week period at Baseline, and over a 1 week period at Week 4

Using wrist actigraphy, this study will objectively monitor each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.

Outcome measures

Outcome measures
Measure	SLEEP-Extend Intervention n=4 Participants Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.	Control Group n=2 Participants Participants receiving one educational session consisting of safety practices used for an urban environment.
Hours of Sleep Baseline	5.18 hours Standard Deviation 0.55	5.78 hours Standard Deviation 0.01
Hours of Sleep Week 4	5.63 hours Standard Deviation 0.92	6.72 hours Standard Deviation 0.41

SECONDARY outcome

Timeframe: Over a 1 week period at Baseline, and over a 1 week period at Week 4

Sleep extension is assessed as the number of participants extending their nightly sleep by 1 to 2 hours from the baseline visit to the week 4 visit, as monitored using wrist actigraphy to measure each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.

Outcome measures

Outcome measures
Measure	SLEEP-Extend Intervention n=4 Participants Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour.	Control Group n=2 Participants Participants receiving one educational session consisting of safety practices used for an urban environment.
Number of Participants Extending Sleep	2 Participants	1 Participants

Adverse Events

SLEEP-Extend Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Ashley Coombe, PhD

Emory University

Phone: 404-712-9313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place