NarcolepsyNCT03904238
Psychosocial Adjunctive Treatment for Hypersomnia (PATH)
A study testing Cognitive-Behavior Therapy for Hypersomnia (CBT-H) in people with Narcolepsy and Idiopathic Hypersomnia, run by Northwestern University at 1 site in United States.
Trial summary
Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy, Idiopathic Hypersomnia
- What is being tested?
- Cognitive-Behavior Therapy for Hypersomnia (CBT-H)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 7 Oct 2019
- 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
- Males and females age 18 and older.
- Meets criteria for Narcolepsy (Type I or II) or Idiopathic Hypersomnia (IH).
- Moderate to severe symptoms of depression.
- Established standard care for CH at a sleep clinic.
Who cannot join
- Hypersomnia not of central origin.
- Current suicidal ideation or intent.
- Uncontrolled medical conditions or physical limitations that require immediate medical treatment that would prevent ability to engage in the treatment protocol.
- Inability to engage in the treatment protocol due to a psychiatric or cognitive issue.
- Untreated moderate-to-severe sleep-related breathing disorder.
- Unable to attend intervention sessions due to accessibility or availability.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Circadian and Sleep Medicine, Northwestern University
Chicago, Illinois, 60611
About this study
Official title: Psychosocial Adjunctive Treatment for Hypersomnia (PATH): A Pilot Trial
Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor health-related quality of life. Unfortunately, there are currently no psychosocial interventions that directly addresses this issue. Therefore, the overall goal of this project is to gather initial outcome data and work out methodological issues to determine if a future pragmatic clinical trial is warranted.
Read the detailed description
Chronic hypersomnia (CH) is a serious and debilitating condition involving persistent excessive daytime sleepiness (EDS) and includes narcolepsy and idiopathic hypersomnia (IH). Currently, pharmacotherapy is the only empirically-validated treatment for reducing EDS in this patient population but the burden of long-term management and adverse effects of the medication lead to poor health-related quality of life (HRQoL) and elevations in depressive symptoms
Evidence-based psychosocial interventions have been developed in other areas to improve HRQoL related to chronic illnesses, such as cancer and chronic pain. These interventions typically involve a package of cognitive and behavioral techniques teaching coping skills (e.g., emotion-focused and problem-focused coping), behavioral management of the chronic illness symptoms (e.g., relaxation for pain management), and other strategies to improve psychosocial functioning (e.g., mindfulness). However, no such interventions have been developed or used for people with CH. Therefore, a major research gap exists for an empirically-validated psychosocial intervention which is aimed directly at improving emotional functioning and HRQoL for people with CH.
The purpose of this project is to develop a cognitive-behavioral treatment for hypersomnia (CBT-H) and conducting a feasibility trial of CBT-H. The specific aims for this project are to: 1) develop and refine a treatment protocol for CBT-H; 2) identify the optimal delivery format of CBT-H; and 3) gather feasibility data on recruitment, retention, and selection criteria for a future clinical trial. The overall significance of this project is to improve the quality of care for people with CH by using a psychosocial intervention with medical management of hypersomnia.
- Conditions
- Narcolepsy, Idiopathic Hypersomnia
- Being tested
- Cognitive-Behavior Therapy for Hypersomnia (CBT-H)
- Keywords
- Hypersomnia, narcolepsy, idiopathic hypersomnia, psychosocial, cognitive-behavior therapy
- Medical subject headings
- Narcolepsy, Idiopathic Hypersomnia, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavior Therapy for Hypersomnia (CBT-H)Behavioural
The CBT-H intervention consists of 6 weekly sessions that are conducted either individually or in small groups. Each session is expected to last about 45 to 60 minutes and will be delivered a study therapist using live videoconferencing or in-person. The treatment package consists of cognitive and behavioral modules that include education about hypersomnia, coping skills training, emotion regulation regarding the perceived limitations of living with chronic hypersomnia (e.g., "I cannot live a full life because of my illness"), and behavioral techniques using scheduled naps, sleep hygiene, and regularizing sleep schedules at night which are on the current optional recommendations for hypersomnia.
| Study group | Role | What they receive |
|---|---|---|
| CBT-H (Individual format) | Experimental | Individual CBT-H consists of 6 weekly sessions that are conducted one-on-one with a study therapist using live videoconferencing or in-person. Each session is expected to last about 45 to 60 minutes. Receives: Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H) |
| CBT-H (Group format) | Experimental | Group-based CBT-H consists of 6 weekly sessions that are conducted in groups with a study therapist using live videoconferencing or in-person. Each session is expected to last about 45 to 60 minutes. The treatment package consists of the same cognitive and behavioral modules as the individual CBT-H. However, participants are also provided the opportunity to share their experiences and provide peer support in the group format. Receives: Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ)
The PHQ is a 9-item self-report scale of depressive symptoms that has been validated to assess the severity of depression in clinical practice. PHQ-9 cut scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Measured: Change from Baseline PHQ at 6 weeks (Post-treatment)
Secondary outcomes (9)
Patient Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Scale
Measures general self-efficacy, self-efficacy for managing emotions, self-efficacy for managing social interactions, self-efficacy for managing symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting better self-efficacy.
Measured: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Measures depressive symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms.
Measured: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Measures anxiety symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms.
Measured: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale
Measures sleep disturbances using Computer Adaptive Testing (CAT) with higher scores reflecting more sleep disturbance.
Measured: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Scale
Measures sleep-related impairment using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.
Measured: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Measures fatigue using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.
Measured: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Phyiscal Function Scale
Measures physical function using Computer Adaptive Testing (CAT) with higher scores reflecting better physical function.
Measured: Baseline to post-treatment (6 weeks)
Epworth Sleepiness Scale (ESS)
The ESS consists of eight questions rated from 0 to 3, with higher scores indicating greater likelihood of falling asleep. Total scores of 10 or greater reflect excessive daytime sleepiness.
Measured: Baseline to post-treatment (6 weeks)
Functional Outcomes of Sleep Questionaire (FOSQ)
The FOSQ assesses the impact of sleepiness on daily behaviors and quality of life. It is comprised of 30 items divided into five subscales: activity level, vigilance, intimate and sexual relationships, general productivity, and social outcome. Items are rated from 1 to 4, with higher score reflecting better functioning.
Measured: Baseline to post-treatment (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start10 Dec 2018
- Primary completion30 Sep 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to receive CBT-H in one of two formats: 1) individually or 2) small groups. However, the contents of the intervention are the same.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Ong, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904238
- Sponsor's protocol ID
- STU00207253
- Other IDs
- 185-SR-17
- Status last verified
- Nov 2019
- First submitted
- 3 Apr 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ong JC, Dawson SC, Mundt JM, Moore C. Developing a cognitive behavioral therapy for hypersomnia using telehealth: a feasibility study. J Clin Sleep Med. 2020 Dec 15;16(12):2047-2062. doi: 10.5664/jcsm.8750.
PubMed 32804069
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Adjunctive Treatment for Hypersomnia (PATH): A Pilot Trial
- ClinicalTrials.gov ID
- NCT03904238
- Acronym / sponsor ID
- STU00207253
- Conditions
- Narcolepsy, Idiopathic Hypersomnia
- Keywords
- Hypersomnia, narcolepsy, idiopathic hypersomnia, psychosocial, cognitive-behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 5 Apr 2019 (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.
Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor health-related quality of life. Unfortunately, there are currently no psychosocial interventions that directly addresses this issue. Therefore, the overall goal of this project is to gather initial outcome data and work out methodological issues to determine if a future pragmatic clinical trial is warranted.
Detailed description
Chronic hypersomnia (CH) is a serious and debilitating condition involving persistent excessive daytime sleepiness (EDS) and includes narcolepsy and idiopathic hypersomnia (IH). Currently, pharmacotherapy is the only empirically-validated treatment for reducing EDS in this patient population but the burden of long-term management and adverse effects of the medication lead to poor health-related quality of life (HRQoL) and elevations in depressive symptoms
Evidence-based psychosocial interventions have been developed in other areas to improve HRQoL related to chronic illnesses, such as cancer and chronic pain. These interventions typically involve a package of cognitive and behavioral techniques teaching coping skills (e.g., emotion-focused and problem-focused coping), behavioral management of the chronic illness symptoms (e.g., relaxation for pain management), and other strategies to improve psychosocial functioning (e.g., mindfulness). However, no such interventions have been developed or used for people with CH. Therefore, a major research gap exists for an empirically-validated psychosocial intervention which is aimed directly at improving emotional functioning and HRQoL for people with CH.
The purpose of this project is to develop a cognitive-behavioral treatment for hypersomnia (CBT-H) and conducting a feasibility trial of CBT-H. The specific aims for this project are to: 1) develop and refine a treatment protocol for CBT-H; 2) identify the optimal delivery format of CBT-H; and 3) gather feasibility data on recruitment, retention, and selection criteria for a future clinical trial. The overall significance of this project is to improve the quality of care for people with CH by using a psychosocial intervention with medical management of hypersomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to receive CBT-H in one of two formats: 1) individually or 2) small groups. However, the contents of the intervention are the same.
| Arm | Type | Receives |
|---|---|---|
| CBT-H (Individual format) | Experimental | Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H)Individual CBT-H consists of 6 weekly sessions that are conducted one-on-one with a study therapist using live videoconferencing or in-person. Each session is expected to last about 45 to 60 minutes. |
| CBT-H (Group format) | Experimental | Behavioral: Cognitive-Behavior Therapy for Hypersomnia (CBT-H)Group-based CBT-H consists of 6 weekly sessions that are conducted in groups with a study therapist using live videoconferencing or in-person. Each session is expected to last about 45 to 60 minutes. The treatment package consists of the same cognitive and behavioral modules as the individual CBT-H. However, participants are also provided the opportunity to share their experiences and provide peer support in the group format. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females age 18 and older.
- Meets criteria for Narcolepsy (Type I or II) or Idiopathic Hypersomnia (IH).
- Moderate to severe symptoms of depression.
- Established standard care for CH at a sleep clinic.
Key exclusion criteria (6 listed)
- Hypersomnia not of central origin.
- Current suicidal ideation or intent.
- Uncontrolled medical conditions or physical limitations that require immediate medical treatment that would prevent ability to engage in the treatment protocol.
- Inability to engage in the treatment protocol due to a psychiatric or cognitive issue.
- Untreated moderate-to-severe sleep-related breathing disorder.
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 |
|---|---|---|
| Cognitive-Behavior Therapy for Hypersomnia (CBT-H)The CBT-H intervention consists of 6 weekly sessions that are conducted either individually or in small groups. Each session is expected to last about 45 to 60 minutes and will be delivered a study therapist using live videoconferencing or in-person. The treatment package consists of cognitive and behavioral modules that include education about hypersomnia, coping skills training, emotion regulation regarding the perceived limitations of living with chronic hypersomnia (e.g., "I cannot live a full life because of my illness"), and behavioral techniques using scheduled naps, sleep hygiene, and regularizing sleep schedules at night which are on the current optional recommendations for hypersomnia. | Behavioural | CBT-H (Group format), CBT-H (Individual format) |
Primary outcome
Patient Health Questionnaire (PHQ)
Time frame: Change from Baseline PHQ at 6 weeks (Post-treatment)
The PHQ is a 9-item self-report scale of depressive symptoms that has been validated to assess the severity of depression in clinical practice. PHQ-9 cut scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
9 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Scale
Time frame: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Time frame: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Time frame: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale
Time frame: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Scale
Time frame: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Time frame: Baseline to post-treatment (6 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Phyiscal Function Scale
Time frame: Baseline to post-treatment (6 weeks)
Epworth Sleepiness Scale (ESS)
Time frame: Baseline to post-treatment (6 weeks)
Functional Outcomes of Sleep Questionaire (FOSQ)
Time frame: Baseline to post-treatment (6 weeks)
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 21 Nov 2019.
- Derived from this study: PubMed 32804069Ong JC, Dawson SC, Mundt JM, Moore C. Developing a cognitive behavioral therapy for hypersomnia using telehealth: a feasibility study. J Clin Sleep Med. 2020 Dec 15;16(12):2047-2062. doi: 10.5664/jcsm.8750.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavior Therapy for Hypersomnia (CBT-H) in people with Narcolepsy and Idiopathic Hypersomnia, run by Northwestern University 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 4 inclusion and 6 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 21 Nov 2019. 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?
Patient Health Questionnaire (PHQ) (time frame: Change from Baseline PHQ at 6 weeks (Post-treatment)). 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 NCT03904238, which also lists 1 linked publication.
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 21 Nov 2019.