Effects of a sleep program on sleep, performance and health in university students

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17008034

Enrollment

118

Registered

2025-10-15

Start date

2027-05-01

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Nervous System Diseases

Interventions

This study is a pragmatic two-arm randomised controlled trial to assess the short- and long-term effects of a sleep program on students with insomnia in a Norwegian University. The intervention is a

co-interventions will be recorded. Participants will be randomly allocated to the intervention group or the waiting list comparison group in a 1:1 ratio. The method of randomised permuted blocks

Eligibility

Sex/Gender

All

Age

18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. Meet the criteria for chronic insomnia disorder based on the Bergen insomnia scale (BIS) 2. Student at the University of southeast Norway (USN), campus Vestfold, with at minimum of two years remaining in your studies 3. Aged 18-30 4. Understand and speak a Scandinavian language 5. Consent to randomisation

Exclusion criteria

Exclusion criteria: 1. Receiving pharmacological or non- pharmacological treatment for sleep problems 2. Sleep apnea, restless legs or periodic limb movements, because this may suggest that other sleep disorders may explain the insomnia symptoms 3. Unstable or severe medical/neurological conditions that substantially affect sleep 4. Current nightshift or rotating-shift work (=1 night shift per week within the past month or anticipated during the trial) 5. Moderate or severe mental illness 6. Moderate or severe health issues related to their insomnia diagnosis 7. Having children 8. Pregnancy

Design outcomes

Primary

Measure	Time frame
Insomnia severity is measured using the Bergen Insomnia scale (BIS) and the Insomnia Severity Index at baseline, 12 weeks and 12 months. A seven-day sleep diary is used to derive standard continuity and timing metrics, including sleep onset latency (SOL), wake after sleep onset (WASO), time in bed (TIB), total sleep time (TST), sleep efficiency (SE = TST/TIB × 100), and sleep midpoint/bed- and rise-times.	—

Measure

Time frame

Insomnia severity is measured using the Bergen Insomnia scale (BIS) and the Insomnia Severity Index at baseline, 12 weeks and 12 months. A seven-day sleep diary is used to derive standard continuity and timing metrics, including sleep onset latency (SOL), wake after sleep onset (WASO), time in bed (TIB), total sleep time (TST), sleep efficiency (SE = TST/TIB × 100), and sleep midpoint/bed- and rise-times.

—

Secondary

Measure	Time frame
All secondary outcome measures are assessed at baseline, 12-weeks and 12-month follow-up, unless stated: 1. Mental health and wellbeing are measured using the Patient Health Questionnaire, Generalized Anxiety Disorder – 7 items, Perceived Stress Scale, World Health Organization – Five Well-Being Index and EuroQol 5 Dimensions – 5 Levels 2. Cognitive function is measured using the Psychomotor Vigilance Task 3. Academic attainment is obtained from university records for periods overlapping post-programme and 12-month follow-up 4. Free-living physical activity, PA and sedentary time, will be assessed using the activPAL monitor (model activPALTM micro; PAL Technologies Ltd, Glasgow, UK) and the International PA Questionnaire Short Form 5. Diet and beverages screener captures frequency of sugar-sweetened beverages/energy drinks, estimated daily caffeine intake from coffee/tea/energy drinks, fruit/vegetable intake, breakfast frequency, and late-evening eating 6. Alcohol and drug use are measured using the Alcohol Use Disorders Identification Test and Drug Use Disorders Identification Test 7. Tobacco and snus use is recorded using the Fagerström Test for Nicotine Dependence 8. Height is measured using a stadiometer, weight with a calibrated scale, and waist circumference is measured using a measuring tape (midpoint between the lowest rib and the iliac crest at end-expiration) 9. Resting blood pressure is measured with an automated sphygmomanometer 10. Body composition is assessed by bioelectrical impedance 11. Maximal oxygen uptake (VO2max) will be assessed through a maximum exercise test on a treadmill. Gas exchange will be continuously sampled in a mixing chamber every 30 s by having the subjects breathe into a Hans Rudolph two-way breathing valve (2700 series, Hans Rudolph Inc., Kansas City, USA). The breathing valve is connected to a Vyntus CPX (Vyaire Medical, Illinois, USA), which is used to analyze the oxygen and carbon dioxide content. 12. Biomarkers: Salivary c	—

Measure

Time frame

All secondary outcome measures are assessed at baseline, 12-weeks and 12-month follow-up, unless stated: 1. Mental health and wellbeing are measured using the Patient Health Questionnaire, Generalized Anxiety Disorder – 7 items, Perceived Stress Scale, World Health Organization – Five Well-Being Index and EuroQol 5 Dimensions – 5 Levels 2. Cognitive function is measured using the Psychomotor Vigilance Task 3. Academic attainment is obtained from university records for periods overlapping post-programme and 12-month follow-up 4. Free-living physical activity, PA and sedentary time, will be assessed using the activPAL monitor (model activPALTM micro; PAL Technologies Ltd, Glasgow, UK) and the International PA Questionnaire Short Form 5. Diet and beverages screener captures frequency of sugar-sweetened beverages/energy drinks, estimated daily caffeine intake from coffee/tea/energy drinks, fruit/vegetable intake, breakfast frequency, and late-evening eating 6. Alcohol and drug use are measured using the Alcohol Use Disorders Identification Test and Drug Use Disorders Identification Test 7. Tobacco and snus use is recorded using the Fagerström Test for Nicotine Dependence 8. Height is measured using a stadiometer, weight with a calibrated scale, and waist circumference is measured using a measuring tape (midpoint between the lowest rib and the iliac crest at end-expiration) 9. Resting blood pressure is measured with an automated sphygmomanometer 10. Body composition is assessed by bioelectrical impedance 11. Maximal oxygen uptake (VO2max) will be assessed through a maximum exercise test on a treadmill. Gas exchange will be continuously sampled in a mixing chamber every 30 s by having the subjects breathe into a Hans Rudolph two-way breathing valve (2700 series, Hans Rudolph Inc., Kansas City, USA). The breathing valve is connected to a Vyntus CPX (Vyaire Medical, Illinois, USA), which is used to analyze the oxygen and carbon dioxide content. 12. Biomarkers: Salivary c

—

Countries

Norway

Contacts

Public ContactEivind Andersen

eivind.andersen@usn.no+47 90059514

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 30, 2026