Treatment of Insomnia in Primary Care Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Turku

About this trial

The goal of this clinical trial is to learn about insomnia treatment among primary care patients with chronic insomnia.

The main question it aims to answer is:

• Does Sleep School (a therapy for insomnia) work well to decrease harm of insomnia? Participants will attend a group therapy intervention once a week for six weeks.

Researchers will compare Sleep School to treatment as usual (short counselling by an educated nurse) to see if the Sleep School works better than treatment as usual in decreasing the harm of insomnia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Insomnia severity index (ISI) score at least 8

insomnia symptoms present at least for 3 months

Disqualifiers

diagnosed dementia based on medical records

acute suicidality

acute psychotic symptoms

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sleep School

    Behavioral

    Sleep school is a structured method for the treatment of insomnia, which is based on cognitive behavioral therapy for insomnia (CBT-I). The central element of the method is a workbook for the patients. The essential parts of the method are strengthening the patient's self-efficacy, introducing the therapeutic exercises, and supporting the continued use of the exercises. The main themes of the Sleep school are information about sleep and the factors affecting it, behavioural components of CBT-I, like restricting the time spent in bed, cognitive components of CBT-I, like constructive worrying -exercise, and the exercises that aim to calm down mind and the autonomic nervous system. The Sleep School is held by an educated nurse.

  • Treatment as usual

    Behavioral

    Oral and written information about improving sleep habits given by an educated nurse.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Sleep SchoolExperimental treatment 1 intervention
Group B: Treatment as usualActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Change from Baseline in Insomnia Severity Index (ISI) score at 8 weeks

The ISI is a validated self-report tool for assessing the severity, and impact of current insomnia symptoms. It consists of 7 Likert-scale questions with a total score ranging from 0 to 28 (with higher scores indicating more severe insomnia). Change = Week 8 score - Baseline score.

Time frame
Baseline and Week 8

Secondary outcomes

1

Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 8 weeks

PHQ-9 is a validated self-administered instrument assessing each of the 9 Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria for depression as 0 (not at all) to 3 (nearly every day), and the severity of depression. Possible scores range from 0 to 27. Change = Week 8 score - Baseline score.

Time frame
Baseline and Week 8
2

Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 8 weeks

EUROHIS Quality of Life 8-item Index is a validated instrument for the assessment of general quality of life. There are altogether eight questions about the general, physical, psychological, social, and environmental aspects of quality of life. Every question is scored from 1 (very poor) to 5 (very good). All scores can be added together and divided by 8 (the sum of the questions) to obtain the EUROHIS-QOL mean score. Change = Week 8 score - Baseline score.

Time frame
Baseline and Week 8
3

Mean change from Baseline in Work Ability Score (WAS) at 8 weeks

The WAS is the first item of the Work Ability Index (WAI), a validated instrument for the assessment of work ability. WAS is a single question "What is your current work ability compared to your lifetime best?" It has a 0-10 response scale, where 0 stands for "completely unable to work" and 10 stands for "work ability at its best." The WAS has been shown to have a strong association with the WAI and is reliable in evaluating work ability. Change = Week 8 score - Baseline score.

Time frame
Baseline and Week 8

Other outcomes

1

Sleep Duration at Baseline

Information about sleep duration is collected with smart watches using a validated method. The method is based on assessment of biological signals with artificial intelligence algorithms. With a smart watch, the participant's heart rate, movements, oxygen saturation, and photoplethysmography signal is measured from the wrist. The photoplethysmography signal measures optically the changes in blood volume, which enables the assessment of the function of the sympathetic and parasympathetic nervous system. Albeit having different units, our previously developed deep learning applications utilize information from heart rate, movements, oxygen saturation, and photoplethysmography signals to assess sleep duration. Thus, regardless of the units of measured signals, information from all of these signals are combined by automatic algorithms to report one single value: sleep duration.

Time frame
Baseline
2

Sleep Stages at Baseline

Information about sleep stages is collected with smart watches using a validated method. The method is based on assessment of biological signals with artificial intelligence algorithms. With a smart watch, the participant's heart rate, movements, oxygen saturation, and photoplethysmography signal is measured from the wrist. The photoplethysmography signal measures optically the changes in blood volume, which enables the assessment of the function of the sympathetic and parasympathetic nervous system. Albeit having different units, our previously developed deep learning applications utilize information from heart rate, movements, oxygen saturation, and photoplethysmography signals to assess sleep stages. Thus, regardless of the units of measured signals, information from all of these signals are combined by automatic algorithms to report one single value: sleep stages.

Time frame
Baseline
3

Sleep Quality at Baseline

Information about objective sleep quality is collected with smart watches using a validated method. The method is based on assessment of biological signals with artificial intelligence algorithms. With a smart watch, the participant's heart rate, movements, oxygen saturation, and photoplethysmography signal is measured from the wrist. The photoplethysmography signal measures optically the changes in blood volume, which enables the assessment of the function of the sympathetic and parasympathetic nervous system. Albeit having different units, our previously developed deep learning applications utilize information from heart rate, movements, oxygen saturation, and photoplethysmography signals to assess sleep quality. Thus, regardless of the units of measured signals, information from all of these signals are combined by automatic algorithms to report one single value: sleep quality.

Time frame
Baseline
4

Sleep Duration at 8 weeks

Information about sleep duration is collected with smart watches using a validated method. The method is based on assessment of biological signals with artificial intelligence algorithms. With a smart watch, the participant's heart rate, movements, oxygen saturation, and photoplethysmography signal is measured from the wrist. The photoplethysmography signal measures optically the changes in blood volume, which enables the assessment of the function of the sympathetic and parasympathetic nervous system. Albeit having different units, our previously developed deep learning applications utilize information from heart rate, movements, oxygen saturation, and photoplethysmography signals to assess sleep duration. Thus, regardless of the units of measured signals, information from all of these signals are combined by automatic algorithms to report one single value: sleep duration.

Time frame
Week 8

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Turku

Lead sponsor

University of Eastern Finland

Collaborator