Sleep DisturbanceNCT05872672
Assessment of a Behavioral Sleep Program in a Population With Sleep Disturbances
A study testing Sleep Program and Waitlist in people with Sleep Disturbance, run by University of Southern Denmark at 1 site in United States.
Trial summary
Sleep disturbances are considered a significant public health concern. The prevalence of disrupted sleep among US adults has increased to alarming levels. Around 70 million Americans suffer from a sleep disturbance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Sleep Program and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A total score of 11 or greater on the Insomnia Severity Index (ISI).
- Fluency in English
- Own a smartphone that can support downloaded apps
Who cannot join
- Completed CBTi program in the past 6 months.
- Risk factors associated with severe insomnia such as depression and self-harm.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Assessment of a Behavioral Sleep Program Using Subjective and Objective Measures of Sleep Quality in a Population With Sleep Disturbances
Sleep disturbances are considered a significant public health concern. The prevalence of disrupted sleep among US adults has increased to alarming levels. Around 70 million Americans suffer from a sleep disturbance. Reduced sleep and poor sleep quality have been linked to cardiovascular disease, increased risk for obesity, hypertension, heart attack, and stroke.
Sleep disturbances are characterized by dissatisfaction with sleep quality or sleep quantity, which may be associated with difficulties initiating sleep, difficulties maintaining sleep, or early-morning awakenings with an inability to return to sleep. Sleep disturbances including insomnia can be treated with pharmacological treatments. However, individuals often report adverse side effects. Increasing attention has therefore been paid to behavioral and psychological interventions, such as cognitive behavioral therapy and mindfulness.
Read more
The study will assess a smartphone-based sleep program by Headspace Health that combines cognitive behavioral therapy for insomnia (CBTi) and mindfulness concepts to minimize nocturnal symptoms and waking consequences associated with sleep disturbances.
The study aims to test the effectiveness of the Headspace Health Sleep Program on self-reported outcomes related to sleep quality. A secondary aim is to test objective measures of sleep quality using actigraphy.
The Headspace Health Sleep Program is an 18 day program based on CBTi, which includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
Read the detailed description
The purpose of the study is to examine the effectiveness of the Headspace Health Sleep Program for improving both subjective sleep quality (i.e., self-reported surveys) as well as objective sleep quality (i.e. actigraphy) in a population with sleep disturbances. The study will employ a 2-arm app-based intervention involving 1 active intervention (i.e., Headspace Health Sleep Program) and a waitlist control for a duration of 18 days.
A set of outcome measures will be used to evaluate the Headspace Health Sleep Program vs. a waitlist control group. The Insomnia Severity Index (ISI) will be used as a primary outcome measure as well as the Sleep Diary, and actigraphy. In addition, secondary outcome measures include Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10), Patient Health Questionnaire-8 (PHQ-8), General Anxiety Disorder-7 (GAD-7) and Mindful Attention Awareness Scale (MAAS). Baseline measures will be taken prior to randomization, and at post-intervention. 2 weeks following the post-intervention assessment, participants will again be asked to report sleep quality using self-reported surveys.
Eligible participants will complete a 1-week baseline assessment period. Participants will be supplied with a wrist actigraph and sleep diary. On the first day of the assessment period, participants will be instructed to start wearing the wrist actigraph. They will also be instructed to complete the sleep diary the following morning. Participants will continue this procedure of filling in the sleep diary every morning for the 1-week baseline assessment period and wearing the wrist actigraph. Following the 1-week baseline assessment period, participants will be asked to return the sleep diary, wrist actigraph, and complete baseline questionnaires (i.e., ISI, PSQI, PSS-10, PHQ8, GAD7, MAAS). They will then be randomized into one of two groups (Headspace Health Sleep Program or waitlist control). Having completed the intervention, participants will be scheduled for the 1-week post-intervention assessment period. Participants will again be supplied with a wrist actigraph, and sleep diary. At the end of this 1-week post-intervention assessment period, participants will return the sleep diary, wrist actigraph, and complete questionnaires (i.e., ISI, PSQI, PSS-10, PHQ8, GAD7, MAAS). 2 weeks following the post-intervention, participants will be asked to complete the sleep diary for a 1-week follow-up assessment period and in addition the ISI, PSQI, PSS-10, PHQ8, GAD7 and MAAS.
- Conditions
- Sleep Disturbance
- Being tested
- Sleep Program, Waitlist
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ProgramBehavioural
Participants will complete the Headspace Health Sleep Program, which is an 18 day program based on CBTi, and includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
WaitlistOther
Participants will continue their regular sleep routines for an 18 day period and will not be assigned to an intervention.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Program | Active comparator | Not described Receives: Behavioral: Sleep Program |
| Waitlist | Other | Not described Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The ISI is a measure of sleep disturbance severity. ISI is a 7-item, self-report measure for the evaluation of insomnia. Items in the ISI concern difficulties falling asleep, problems staying asleep, daytime symptoms connected to the sleeping problem, and worrying about sleeping too little. Each item is rated from 0 to 4, giving the rating scale a maximum summed score of 28 points. According to the guidelines for interpretation, 0-7 should be interpreted as no clinically significant insomnia, 8-14 as subthreshold insomnia, 15-21 as clinical insomnia of moderate severity, and 22-28 as severe clinical insomnia.
Measured: Change from baseline to immediately post-intervention and 2-week follow-up
Sleep Diary
Participants will be asked to complete a daily sleep diary for the duration of the 1-week baseline assessment period and the 1-week post-intervention assessment and the 1-week follow-up period. The sleep diary will be used to measure sleep efficiency (SE) and total wake time (TWT). Sleep efficiency will be calculated by dividing the amount of time sleeping in bed by the amount of time spent in bed. Total sleep time will be calculated as the total amount of nightly sleep. In addition, the sleep diary will measure sleep onset latency (SOL), wake after sleep onset (WASO). The sleep diary data will be averaged across one week with a minimum of 4 nights required for inclusion.
Measured: Change from baseline to immediately post-intervention and 2-week follow-up
Actigraphy
A wrist actigraph will be worn on the non-dominant wrist of participants for the duration of the 1-week baseline assessment period and the 1-week post-intervention assessment period. In this study the investigators will use the research-grade GT3X actigraph (wGT3X-BT: ActiGraph, Pensacola, Florida, USA), which is a small (10.5 × 30.3 × 40.6 mm) and lightweight (19 g) triaxial accelerometer and is a research-grade device. The investigators will use the ActiLife (Version 6.13.1, ActiGraph, Pensacola, Florida, USA) data analysis software to extract the variables of interest. An algorithm yields approximate values for sleep efficiency, sleep onset latency, wake after sleep onset, movement time, total wake time (TWT) and sleep fragmentation. Participants will be instructed to wear the wrist actigraph continuously in the 1-week baseline and 1-week post intervention periods. Actigraphy data will be averaged across one week with a minimum of 4 nights required for inclusion.
Measured: Change from baseline to immediately post-intervention
Secondary outcomes (6)
The Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances. 19 individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Higher scores indicate worse sleep quality where poor sleep will be a PSQI total score of > 5.
Measured: Change from baseline to immediately post-intervention and 2-week follow-up
Perceived Stress Scale (PSS-10)
The PSS is a 10-item scale designed to measure the perception of stress within the past month. Participants use a Likert scale with responses ranging from 0 = never to 4 = very often. PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. Additionally, scores can be categorized as low (0-13), moderate (14-26), and high (27-40) perceived stress.
Measured: Change from baseline to immediately post-intervention and 2-week follow-up
Patient Health Questionnaire-8 (PHQ8)
The PHQ-8 is used to measure depression symptoms. The PHQ-8 consists of 8 items. Participants use a Likert scale ranging from 0 = not at all to 3 = nearly every day. The range of PHQ-8 scores is 0-24.
Measured: Change from baseline to immediately post-intervention and 2-week follow-up
General Anxiety Disorder-7 (GAD-7)
The GAD-7 is a 7-item self-report scale based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for generalized anxiety disorder, with items scored from 0 (not at all) to 3 (nearly every day).
Measured: Change from baseline to immediately post-intervention and 2-week follow-up
Mindful Attention Awareness Scale (MAAS)
Mindfulness will be measured by the MAAS. The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Each of the 15 items aims at measuring one's awareness of what is taking place at the present. The MAAS is answered on a five-point Likert scale. Higher scores reflect higher dispositional mindfulness.
Measured: Change from baseline to immediately post-intervention and 2-week follow-up
Sleep medication
Change in sleep medication will be assessed. Specifically, prescribed sleep medication, over-the-counter sleep aids, therapy, psychotropic medications (SSRIs/anxiety meds).
Measured: Change from baseline to immediately post-intervention and 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Nov 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Ulrich Kirk, University of Southern Denmark
- Investigators
- Ulrich Kirk, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872672
- Sponsor's protocol ID
- 3425432
- Status last verified
- Jun 2024
- First submitted
- 8 May 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated data collected in this project will be de-identified and made available on a shared secured data repository. Results from this project will be shared and disseminated, including manuscripts will be written and submitted for publication in peer-reviewed journals/conferences. All necessary ethical approvals will be obtained.
Publications
Altman NG, Izci-Balserak B, Schopfer E, Jackson N, Rattanaumpawan P, Gehrman PR, Patel NP, Grandner MA. Sleep duration versus sleep insufficiency as predictors of cardiometabolic health outcomes. Sleep Med. 2012 Dec;13(10):1261-70. doi: 10.1016/j.sleep.2012.08.005. Epub 2012 Nov 8.
PubMed 23141932Anderson T, Corneau G, Wideman L, Eddington K, Vrshek-Schallhorn S. The impact of prior day sleep and physical activity on the cortisol awakening response. Psychoneuroendocrinology. 2021 Apr;126:105131. doi: 10.1016/j.psyneuen.2021.105131. Epub 2021 Jan 14.
PubMed 33493753Arble DM, Bass J, Behn CD, Butler MP, Challet E, Czeisler C, Depner CM, Elmquist J, Franken P, Grandner MA, Hanlon EC, Keene AC, Joyner MJ, Karatsoreos I, Kern PA, Klein S, Morris CJ, Pack AI, Panda S, Ptacek LJ, Punjabi NM, Sassone-Corsi P, Scheer FA, Saxena R, Seaquest ER, Thimgan MS, Van Cauter E, Wright KP. Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions. Sleep. 2015 Dec 1;38(12):1849-60. doi: 10.5665/sleep.5226.
PubMed 26564131Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Buysse DJ, Thompson W, Scott J, Franzen PL, Germain A, Hall M, Moul DE, Nofzinger EA, Kupfer DJ. Daytime symptoms in primary insomnia: a prospective analysis using ecological momentary assessment. Sleep Med. 2007 Apr;8(3):198-208. doi: 10.1016/j.sleep.2006.10.006. Epub 2007 Mar 23.
PubMed 17368098Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Cunnington D, Junge MF, Fernando AT. Insomnia: prevalence, consequences and effective treatment. Med J Aust. 2013 Oct 21;199(8):S36-40. doi: 10.5694/mja13.10718.
PubMed 24138364Grandner MA, Schopfer EA, Sands-Lincoln M, Jackson N, Malhotra A. Relationship between sleep duration and body mass index depends on age. Obesity (Silver Spring). 2015 Dec;23(12):2491-8. doi: 10.1002/oby.21247. Epub 2015 Nov 2.
PubMed 26727118Grandner MA, Chakravorty S, Perlis ML, Oliver L, Gurubhagavatula I. Habitual sleep duration associated with self-reported and objectively determined cardiometabolic risk factors. Sleep Med. 2014 Jan;15(1):42-50. doi: 10.1016/j.sleep.2013.09.012. Epub 2013 Oct 28.
PubMed 24333222Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
PubMed 18752852Knutson KL, Spiegel K, Penev P, Van Cauter E. The metabolic consequences of sleep deprivation. Sleep Med Rev. 2007 Jun;11(3):163-78. doi: 10.1016/j.smrv.2007.01.002. Epub 2007 Apr 17.
PubMed 17442599Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
PubMed 21532953Richey SM, Krystal AD. Pharmacological advances in the treatment of insomnia. Curr Pharm Des. 2011;17(15):1471-5. doi: 10.2174/138161211796197052.
PubMed 21476952
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Behavioral Sleep Program Using Subjective and Objective Measures of Sleep Quality in a Population With Sleep Disturbances
- ClinicalTrials.gov ID
- NCT05872672
- Acronym / sponsor ID
- 3425432
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep disturbances are considered a significant public health concern. The prevalence of disrupted sleep among US adults has increased to alarming levels. Around 70 million Americans suffer from a sleep disturbance. Reduced sleep and poor sleep quality have been linked to cardiovascular disease, increased risk for obesity, hypertension, heart attack, and stroke.
Sleep disturbances are characterized by dissatisfaction with sleep quality or sleep quantity, which may be associated with difficulties initiating sleep, difficulties maintaining sleep, or early-morning awakenings with an inability to return to sleep. Sleep disturbances including insomnia can be treated with pharmacological treatments. However, individuals often report adverse side effects. Increasing attention has therefore been paid to behavioral and psychological interventions, such as cognitive behavioral therapy and mindfulness.
The study will assess a smartphone-based sleep program by Headspace Health that combines cognitive behavioral therapy for insomnia (CBTi) and mindfulness concepts to minimize nocturnal symptoms and waking consequences associated with sleep disturbances.
The study aims to test the effectiveness of the Headspace Health Sleep Program on self-reported outcomes related to sleep quality. A secondary aim is to test objective measures of sleep quality using actigraphy.
The Headspace Health Sleep Program is an 18 day program based on CBTi, which includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
Detailed description
The purpose of the study is to examine the effectiveness of the Headspace Health Sleep Program for improving both subjective sleep quality (i.e., self-reported surveys) as well as objective sleep quality (i.e. actigraphy) in a population with sleep disturbances. The study will employ a 2-arm app-based intervention involving 1 active intervention (i.e., Headspace Health Sleep Program) and a waitlist control for a duration of 18 days.
A set of outcome measures will be used to evaluate the Headspace Health Sleep Program vs. a waitlist control group. The Insomnia Severity Index (ISI) will be used as a primary outcome measure as well as the Sleep Diary, and actigraphy. In addition, secondary outcome measures include Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10), Patient Health Questionnaire-8 (PHQ-8), General Anxiety Disorder-7 (GAD-7) and Mindful Attention Awareness Scale (MAAS). Baseline measures will be taken prior to randomization, and at post-intervention. 2 weeks following the post-intervention assessment, participants will again be asked to report sleep quality using self-reported surveys.
Eligible participants will complete a 1-week baseline assessment period. Participants will be supplied with a wrist actigraph and sleep diary. On the first day of the assessment period, participants will be instructed to start wearing the wrist actigraph. They will also be instructed to complete the sleep diary the following morning. Participants will continue this procedure of filling in the sleep diary every morning for the 1-week baseline assessment period and wearing the wrist actigraph. Following the 1-week baseline assessment period, participants will be asked to return the sleep diary, wrist actigraph, and complete baseline questionnaires (i.e., ISI, PSQI, PSS-10, PHQ8, GAD7, MAAS). They will then be randomized into one of two groups (Headspace Health Sleep Program or waitlist control). Having completed the intervention, participants will be scheduled for the 1-week post-intervention assessment period. Participants will again be supplied with a wrist actigraph, and sleep diary. At the end of this 1-week post-intervention assessment period, participants will return the sleep diary, wrist actigraph, and complete questionnaires (i.e., ISI, PSQI, PSS-10, PHQ8, GAD7, MAAS). 2 weeks following the post-intervention, participants will be asked to complete the sleep diary for a 1-week follow-up assessment period and in addition the ISI, PSQI, PSS-10, PHQ8, GAD7 and MAAS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Program | Active comparator | Behavioral: Sleep Program |
| Waitlist | Other | Other: Waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A total score of 11 or greater on the Insomnia Severity Index (ISI).
- Fluency in English
- Own a smartphone that can support downloaded apps
Key exclusion criteria (2 listed)
- Completed CBTi program in the past 6 months.
- Risk factors associated with severe insomnia such as depression and self-harm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep ProgramParticipants will complete the Headspace Health Sleep Program, which is an 18 day program based on CBTi, and includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises). | Behavioural | Sleep Program |
| WaitlistParticipants will continue their regular sleep routines for an 18 day period and will not be assigned to an intervention. | Other | Waitlist |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Change from baseline to immediately post-intervention and 2-week follow-up
The ISI is a measure of sleep disturbance severity. ISI is a 7-item, self-report measure for the evaluation of insomnia. Items in the ISI concern difficulties falling asleep, problems staying asleep, daytime symptoms connected to the sleeping problem, and worrying about sleeping too little. Each item is rated from 0 to 4, giving the rating scale a maximum summed score of 28 points. According to the guidelines for interpretation, 0-7 should be interpreted as no clinically significant insomnia, 8-14 as subthreshold insomnia, 15-21 as clinical insomnia of moderate severity, and 22-28 as severe clinical insomnia.
Sleep Diary
Time frame: Change from baseline to immediately post-intervention and 2-week follow-up
Participants will be asked to complete a daily sleep diary for the duration of the 1-week baseline assessment period and the 1-week post-intervention assessment and the 1-week follow-up period. The sleep diary will be used to measure sleep efficiency (SE) and total wake time (TWT). Sleep efficiency will be calculated by dividing the amount of time sleeping in bed by the amount of time spent in bed. Total sleep time will be calculated as the total amount of nightly sleep. In addition, the sleep diary will measure sleep onset latency (SOL), wake after sleep onset (WASO). The sleep diary data will be averaged across one week with a minimum of 4 nights required for inclusion.
Actigraphy
Time frame: Change from baseline to immediately post-intervention
A wrist actigraph will be worn on the non-dominant wrist of participants for the duration of the 1-week baseline assessment period and the 1-week post-intervention assessment period. In this study the investigators will use the research-grade GT3X actigraph (wGT3X-BT: ActiGraph, Pensacola, Florida, USA), which is a small (10.5 × 30.3 × 40.6 mm) and lightweight (19 g) triaxial accelerometer and is a research-grade device. The investigators will use the ActiLife (Version 6.13.1, ActiGraph, Pensacola, Florida, USA) data analysis software to extract the variables of interest. An algorithm yields approximate values for sleep efficiency, sleep onset latency, wake after sleep onset, movement time, total wake time (TWT) and sleep fragmentation. Participants will be instructed to wear the wrist actigraph continuously in the 1-week baseline and 1-week post intervention periods. Actigraphy data will be averaged across one week with a minimum of 4 nights required for inclusion.
6 secondary outcomes
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline to immediately post-intervention and 2-week follow-up
Perceived Stress Scale (PSS-10)
Time frame: Change from baseline to immediately post-intervention and 2-week follow-up
Patient Health Questionnaire-8 (PHQ8)
Time frame: Change from baseline to immediately post-intervention and 2-week follow-up
General Anxiety Disorder-7 (GAD-7)
Time frame: Change from baseline to immediately post-intervention and 2-week follow-up
Mindful Attention Awareness Scale (MAAS)
Time frame: Change from baseline to immediately post-intervention and 2-week follow-up
Sleep medication
Time frame: Change from baseline to immediately post-intervention and 2-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 23141932Altman NG, Izci-Balserak B, Schopfer E, Jackson N, Rattanaumpawan P, Gehrman PR, Patel NP, Grandner MA. Sleep duration versus sleep insufficiency as predictors of cardiometabolic health outcomes. Sleep Med. 2012 Dec;13(10):1261-70. doi: 10.1016/j.sleep.2012.08.005. Epub 2012 Nov 8.
- Background: PubMed 33493753Anderson T, Corneau G, Wideman L, Eddington K, Vrshek-Schallhorn S. The impact of prior day sleep and physical activity on the cortisol awakening response. Psychoneuroendocrinology. 2021 Apr;126:105131. doi: 10.1016/j.psyneuen.2021.105131. Epub 2021 Jan 14.
- Background: PubMed 26564131Arble DM, Bass J, Behn CD, Butler MP, Challet E, Czeisler C, Depner CM, Elmquist J, Franken P, Grandner MA, Hanlon EC, Keene AC, Joyner MJ, Karatsoreos I, Kern PA, Klein S, Morris CJ, Pack AI, Panda S, Ptacek LJ, Punjabi NM, Sassone-Corsi P, Scheer FA, Saxena R, Seaquest ER, Thimgan MS, Van Cauter E, Wright KP. Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions. Sleep. 2015 Dec 1;38(12):1849-60. doi: 10.5665/sleep.5226.
- Background: PubMed 11438246Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Background: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 17368098Buysse DJ, Thompson W, Scott J, Franzen PL, Germain A, Hall M, Moul DE, Nofzinger EA, Kupfer DJ. Daytime symptoms in primary insomnia: a prospective analysis using ecological momentary assessment. Sleep Med. 2007 Apr;8(3):198-208. doi: 10.1016/j.sleep.2006.10.006. Epub 2007 Mar 23.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 24138364Cunnington D, Junge MF, Fernando AT. Insomnia: prevalence, consequences and effective treatment. Med J Aust. 2013 Oct 21;199(8):S36-40. doi: 10.5694/mja13.10718.
- Background: PubMed 26727118Grandner MA, Schopfer EA, Sands-Lincoln M, Jackson N, Malhotra A. Relationship between sleep duration and body mass index depends on age. Obesity (Silver Spring). 2015 Dec;23(12):2491-8. doi: 10.1002/oby.21247. Epub 2015 Nov 2.
- Background: PubMed 24333222Grandner MA, Chakravorty S, Perlis ML, Oliver L, Gurubhagavatula I. Habitual sleep duration associated with self-reported and objectively determined cardiometabolic risk factors. Sleep Med. 2014 Jan;15(1):42-50. doi: 10.1016/j.sleep.2013.09.012. Epub 2013 Oct 28.
- Background: PubMed 18752852Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
- Individual participant dataSharing planned: Yes. Aggregated data collected in this project will be de-identified and made available on a shared secured data repository. Results from this project will be shared and disseminated, including manuscripts will be written and submitted for publication in peer-reviewed journals/conferences. All necessary ethical approvals will be obtained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Kirk, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Program and Waitlist in people with Sleep Disturbance, run by University of Southern Denmark at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Change from baseline to immediately post-intervention and 2-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05872672, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.