University of Turku
Turku, 20014, Finland
Location status: Recruiting
NCT Number: NCT06149273
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Turku, 20014, Finland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Oral and written information about improving sleep habits given by an educated nurse.
Time frame: Baseline and Week 8
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
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
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
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
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
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
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: Week 8
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
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: Week 8
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: Week 8 and Week 16
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 16 score - Week 8 score.
Time frame: Baseline and Week 16
PHQ-9 is a validated self-administered instrument assessing each of the 9 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 16 score - Baseline score.
Time frame: Baseline and Week 16
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 16 score - Baseline score.
Time frame: Baseline and Week 16
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 16 score - Baseline score.
Time frame: Week 16
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 16
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: Week 16
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: Week 8 and Week 26
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 26 score - Week 8 score.
Time frame: Baseline and Week 26
PHQ-9 is a validated self-administered instrument assessing each of the 9 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 26 score - Baseline.
Time frame: Baseline and Week 26
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 26 score - Baseline score.
Time frame: Baseline and Week 26
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 26 score - Baseline score.
Time frame: Week 26
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 26
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: Week 26
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: Week 8 and 12 Months
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 = 12 Month score - Week 8 score.
Time frame: Baseline and 12 Months
PHQ-9 is a validated self-administered instrument assessing each of the 9 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 = 12 Month score - Baseline score.
Time frame: Baseline and 12 Months
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 = 12 Month score - Baseline score.
Time frame: Baseline and 12 Months
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 = 12 Month score - Baseline score.
Contact information is provided by the study sponsor or research team.
University of Turku
Other
Acronym: TIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06636006
Anxiety Disorders, Behavior
Jatai, Goiás, Brazil
View Trial DetailsNCT05917379
Anxiety, Anxiety Disorders
Hefei, Anhui, China
View Trial DetailsNCT05041647
Behavior, Behavioral Symptoms
Hamilton, Ontario, Canada
View Trial DetailsNCT04719143
Behavior, Behavioral Symptoms
Philadelphia, Pennsylvania, United States
View Trial Details