Sleep Apnea, ObstructiveCOMMENCENCT01377584
COMMunication and Education for the New CPAP Experience
A study testing Couple-oriented intervention, Patient-oriented intervention and Continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Couple-oriented intervention, Patient-oriented intervention and Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient:
- Age is 21 years of age and older
- Have spouse or partner
- Polysomnographically (PSG) diagnosed OSA (AHI ≥ 5)
- Choice of continuous positive airway pressure (CPAP) as preferred treatment
- Partner:
- Age is 18 years of age and older
- Have spouse or partner who has been diagnosed with OSA and has chosen CPAP as preferred treatment
Who cannot join
- Patient:
- AHI < 5 on the diagnostic PSG
- Have a spouse or partner with OSA diagnosis and on OSA treatment
- Past treatment for OSA
- Diagnosis of a sleep disorder other than OSA that cause arousals from sleep (e.g., central sleep apnea, periodic limb movement disorder, insomnia)
- Diagnosis of a serious medical condition (e.g., end stage renal failure, severe chronic obstructive lung disease, severe asthma)
- History of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder) partner:
- Have been diagnosed with OSA and using CPAP
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: COMMENCE Study: COMMunication and Education for the New CPAP Experience
The purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).
Read the detailed description
Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea (OSA), but adherence is poor. CPAP adherence interventions to date have been met with limited success. Intervention strategies would be optimized by added support for patients and alternative strategies for intervention delivery. Significant others (SO) are likely to exert positive and negative effects on the patient's adoption and use of positive airway pressure (PAP) therapy and are frequently described as the greatest source of social support for patients with chronic illness. Beginning the intervention before PAP initiation would capitalize on the teachable moment shortly following diagnosis when education and social support may be most essential. The aims of the research plan are to examine the effects of a couple-oriented education and support intervention on patient- and partner-reported outcomes as compared to a patient-oriented education and support intervention and usual care and to examine the relationship between PAP adherence and patients' and partners' sleep quality and daytime functioning. Patients in the pilot study will be randomized to the couple-oriented intervention, patient-oriented intervention, or standard clinical care group.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Couple-oriented intervention, Patient-oriented intervention, Continuous positive airway pressure (CPAP), No intervention
- Keywords
- Continuous Positive Airway Pressure, Patient Compliance, Intervention Studies, Spouses
- Medical subject headings
- Sleep Apnea, Obstructive, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-oriented interventionBehavioural
The first session will occur before the patient receives his/her CPAP and will last approximately 2 hours. This session will provide the couple with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately one and a half hours. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use.
Patient-oriented interventionBehavioural
The first session will occur before the patient receives his/her CPAP and will last approximately one and a half hours. This session will provide the patient with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately 45 minutes. The second session will provide information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up session will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use.
Continuous positive airway pressure (CPAP)Device
CPAP is treatment for obstructive sleep apnea. CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping.
No interventionOther
No intervention will be received.
| Study group | Role | What they receive |
|---|---|---|
| Patients in the Couple-oriented intervention | Experimental | Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with their partner and participate in an individual telephone follow-up session. Receives: Behavioral: Couple-oriented intervention; Device: Continuous positive airway pressure (CPAP) |
| Patients in Usual Care | Other | Patients will not attend any intervention sessions. Receives: Device: Continuous positive airway pressure (CPAP) |
| Patients in the Patient-oriented intervention | Experimental | Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session. Receives: Behavioral: Patient-oriented intervention; Device: Continuous positive airway pressure (CPAP) |
| Partners in the Couple-oriented intervention | Experimental | Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session. Receives: Behavioral: Couple-oriented intervention |
| Partners in Usual Care | Other | Partners will not attend any intervention sessions. Receives: Other: No intervention |
| Partners in the Patient-oriented intervention | Experimental | Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. Receives: Behavioral: Patient-oriented intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime Sleepiness
The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of > 10 indicates excessive daytime sleepiness.
Measured: baseline and 3 months after CPAP initiation
Sleep-related Functional Outcomes
The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning.
Measured: baseline and 3 months after CPAP initiation
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score > 5 indicates a poor sleeper.
Measured: baseline and 3 months after CPAP initiation
Secondary outcomes (1)
Continuous Positive Airway Pressure (CPAP) Adherence
Adherence will be measured as the amount of time that the CPAP machine is turned on and maintained at prescribed pressure. The latter number represents the amount of time power is on and the mask is positioned properly on the face. All patients will be using a CPAP machine with remote monitoring capabilities. Adherence reports are automatically uploaded to a secure data center daily. Adherence data can be accessed through the web-based patient compliance management system, EncoreAnywhere.
Measured: one week, one month, and 3 months after CPAP initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startMar 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Faith Luyster, University of Pittsburgh
- Investigators
- Faith S Luyster, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377584
- Sponsor's protocol ID
- 1K23HL105887-01A1
- Acronym
- COMMENCE
- Status last verified
- Sep 2017
- First submitted
- 17 Jun 2011
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cartwright R. Sleeping together: a pilot study of the effects of shared sleeping on adherence to CPAP treatment in obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):123-7.
PubMed 18468310Hoy CJ, Vennelle M, Kingshott RN, Engleman HM, Douglas NJ. Can intensive support improve continuous positive airway pressure use in patients with the sleep apnea/hypopnea syndrome? Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1096-100. doi: 10.1164/ajrccm.159.4.9808008.
PubMed 10194151Baron KG, Smith TW, Berg CA, Czajkowski LA, Gunn H, Jones CR. Spousal involvement in CPAP adherence among patients with obstructive sleep apnea. Sleep Breath. 2011 Sep;15(3):525-34. doi: 10.1007/s11325-010-0374-z. Epub 2010 Jun 15.
PubMed 20549372Baron KG, Smith TW, Czajkowski LA, Gunn HE, Jones CR. Relationship quality and CPAP adherence in patients with obstructive sleep apnea. Behav Sleep Med. 2009;7(1):22-36. doi: 10.1080/15402000802577751.
PubMed 19116799Bazzano LA, Khan Z, Reynolds K, He J. Effect of nocturnal nasal continuous positive airway pressure on blood pressure in obstructive sleep apnea. Hypertension. 2007 Aug;50(2):417-23. doi: 10.1161/HYPERTENSIONAHA.106.085175. Epub 2007 Jun 4.
PubMed 17548722Campos-Rodriguez F, Pena-Grinan N, Reyes-Nunez N, De la Cruz-Moron I, Perez-Ronchel J, De la Vega-Gallardo F, Fernandez-Palacin A. Mortality in obstructive sleep apnea-hypopnea patients treated with positive airway pressure. Chest. 2005 Aug;128(2):624-33. doi: 10.1378/chest.128.2.624.
PubMed 16100147Aloia MS, Arnedt JT, Riggs RL, Hecht J, Borrelli B. Clinical management of poor adherence to CPAP: motivational enhancement. Behav Sleep Med. 2004;2(4):205-22. doi: 10.1207/s15402010bsm0204_3.
PubMed 15600056Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.
PubMed 20880872Aloia MS, Di Dio L, Ilniczky N, Perlis ML, Greenblatt DW, Giles DE. Improving compliance with nasal CPAP and vigilance in older adults with OAHS. Sleep Breath. 2001;5(1):13-21. doi: 10.1007/s11325-001-0013-9.
PubMed 11868136Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med. 2005 Oct 15;1(4):346-53.
PubMed 17564399Aloia MS, Arnedt JT, Stanchina M, Millman RP. How early in treatment is PAP adherence established? Revisiting night-to-night variability. Behav Sleep Med. 2007;5(3):229-40. doi: 10.1080/15402000701264005.
PubMed 17680733Weaver TE, Maislin G, Dinges DF, Bloxham T, George CF, Greenberg H, Kader G, Mahowald M, Younger J, Pack AI. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007 Jun;30(6):711-9. doi: 10.1093/sleep/30.6.711.
PubMed 17580592Weaver TE, Kribbs NB, Pack AI, Kline LR, Chugh DK, Maislin G, Smith PL, Schwartz AR, Schubert NM, Gillen KA, Dinges DF. Night-to-night variability in CPAP use over the first three months of treatment. Sleep. 1997 Apr;20(4):278-83. doi: 10.1093/sleep/20.4.278.
PubMed 9231953Berg CA, Upchurch R. A developmental-contextual model of couples coping with chronic illness across the adult life span. Psychol Bull. 2007 Nov;133(6):920-54. doi: 10.1037/0033-2909.133.6.920.
PubMed 17967089Engleman HM, Martin SE, Douglas NJ. Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. Thorax. 1994 Mar;49(3):263-6. doi: 10.1136/thx.49.3.263.
PubMed 8202884
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMMENCE Study: COMMunication and Education for the New CPAP Experience
- ClinicalTrials.gov ID
- NCT01377584
- Acronym / sponsor ID
- COMMENCE / 1K23HL105887-01A1
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Continuous Positive Airway Pressure, Patient Compliance, Intervention Studies, Spouses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Posted 2 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).
Detailed description
Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea (OSA), but adherence is poor. CPAP adherence interventions to date have been met with limited success. Intervention strategies would be optimized by added support for patients and alternative strategies for intervention delivery. Significant others (SO) are likely to exert positive and negative effects on the patient's adoption and use of positive airway pressure (PAP) therapy and are frequently described as the greatest source of social support for patients with chronic illness. Beginning the intervention before PAP initiation would capitalize on the teachable moment shortly following diagnosis when education and social support may be most essential. The aims of the research plan are to examine the effects of a couple-oriented education and support intervention on patient- and partner-reported outcomes as compared to a patient-oriented education and support intervention and usual care and to examine the relationship between PAP adherence and patients' and partners' sleep quality and daytime functioning. Patients in the pilot study will be randomized to the couple-oriented intervention, patient-oriented intervention, or standard clinical care group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients in the Couple-oriented intervention | Experimental | Behavioral: Couple-oriented intervention, Device: Continuous positive airway pressure (CPAP)Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with their partner and participate in an individual telephone follow-up session. |
| Patients in Usual Care | Other | Device: Continuous positive airway pressure (CPAP)Patients will not attend any intervention sessions. |
| Patients in the Patient-oriented intervention | Experimental | Behavioral: Patient-oriented intervention, Device: Continuous positive airway pressure (CPAP)Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session. |
| Partners in the Couple-oriented intervention | Experimental | Behavioral: Couple-oriented interventionPartners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session. |
| Partners in Usual Care | Other | Other: No interventionPartners will not attend any intervention sessions. |
| Partners in the Patient-oriented intervention | Experimental | Behavioral: Patient-oriented interventionPartners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age is 21 years of age and older
- Have spouse or partner
- Polysomnographically (PSG) diagnosed OSA (AHI ≥ 5)
- Choice of continuous positive airway pressure (CPAP) as preferred treatment
- Age is 18 years of age and older
Key exclusion criteria (8 listed)
- AHI < 5 on the diagnostic PSG
- Have a spouse or partner with OSA diagnosis and on OSA treatment
- Past treatment for OSA
- Diagnosis of a sleep disorder other than OSA that cause arousals from sleep (e.g., central sleep apnea, periodic limb movement disorder, insomnia)
- Diagnosis of a serious medical condition (e.g., end stage renal failure, severe chronic obstructive lung disease, severe asthma)
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 |
|---|---|---|
| Couple-oriented interventionThe first session will occur before the patient receives his/her CPAP and will last approximately 2 hours. This session will provide the couple with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately one and a half hours. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use. | Behavioural | Partners in the Couple-oriented intervention, Patients in the Couple-oriented intervention |
| Patient-oriented interventionThe first session will occur before the patient receives his/her CPAP and will last approximately one and a half hours. This session will provide the patient with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately 45 minutes. The second session will provide information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up session will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use. | Behavioural | Partners in the Patient-oriented intervention, Patients in the Patient-oriented intervention |
| Continuous positive airway pressure (CPAP)CPAP is treatment for obstructive sleep apnea. CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping. | Device | Patients in Usual Care, Patients in the Couple-oriented intervention, Patients in the Patient-oriented intervention |
| No interventionNo intervention will be received. | Other | Partners in Usual Care |
Primary outcome
Daytime Sleepiness
Time frame: baseline and 3 months after CPAP initiation
The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of > 10 indicates excessive daytime sleepiness.
Sleep-related Functional Outcomes
Time frame: baseline and 3 months after CPAP initiation
The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning.
Sleep Quality
Time frame: baseline and 3 months after CPAP initiation
The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score > 5 indicates a poor sleeper.
1 secondary outcome
Continuous Positive Airway Pressure (CPAP) Adherence
Time frame: one week, one month, and 3 months after CPAP initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18468310Cartwright R. Sleeping together: a pilot study of the effects of shared sleeping on adherence to CPAP treatment in obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):123-7.
- Background: PubMed 10194151Hoy CJ, Vennelle M, Kingshott RN, Engleman HM, Douglas NJ. Can intensive support improve continuous positive airway pressure use in patients with the sleep apnea/hypopnea syndrome? Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1096-100. doi: 10.1164/ajrccm.159.4.9808008.
- Background: PubMed 20549372Baron KG, Smith TW, Berg CA, Czajkowski LA, Gunn H, Jones CR. Spousal involvement in CPAP adherence among patients with obstructive sleep apnea. Sleep Breath. 2011 Sep;15(3):525-34. doi: 10.1007/s11325-010-0374-z. Epub 2010 Jun 15.
- Background: PubMed 19116799Baron KG, Smith TW, Czajkowski LA, Gunn HE, Jones CR. Relationship quality and CPAP adherence in patients with obstructive sleep apnea. Behav Sleep Med. 2009;7(1):22-36. doi: 10.1080/15402000802577751.
- Background: PubMed 17548722Bazzano LA, Khan Z, Reynolds K, He J. Effect of nocturnal nasal continuous positive airway pressure on blood pressure in obstructive sleep apnea. Hypertension. 2007 Aug;50(2):417-23. doi: 10.1161/HYPERTENSIONAHA.106.085175. Epub 2007 Jun 4.
- Background: PubMed 16100147Campos-Rodriguez F, Pena-Grinan N, Reyes-Nunez N, De la Cruz-Moron I, Perez-Ronchel J, De la Vega-Gallardo F, Fernandez-Palacin A. Mortality in obstructive sleep apnea-hypopnea patients treated with positive airway pressure. Chest. 2005 Aug;128(2):624-33. doi: 10.1378/chest.128.2.624.
- Background: PubMed 15600056Aloia MS, Arnedt JT, Riggs RL, Hecht J, Borrelli B. Clinical management of poor adherence to CPAP: motivational enhancement. Behav Sleep Med. 2004;2(4):205-22. doi: 10.1207/s15402010bsm0204_3.
- Background: PubMed 20880872Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.
- Background: PubMed 11868136Aloia MS, Di Dio L, Ilniczky N, Perlis ML, Greenblatt DW, Giles DE. Improving compliance with nasal CPAP and vigilance in older adults with OAHS. Sleep Breath. 2001;5(1):13-21. doi: 10.1007/s11325-001-0013-9.
- Background: PubMed 17564399Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med. 2005 Oct 15;1(4):346-53.
- Background: PubMed 17680733Aloia MS, Arnedt JT, Stanchina M, Millman RP. How early in treatment is PAP adherence established? Revisiting night-to-night variability. Behav Sleep Med. 2007;5(3):229-40. doi: 10.1080/15402000701264005.
- Background: PubMed 17580592Weaver TE, Maislin G, Dinges DF, Bloxham T, George CF, Greenberg H, Kader G, Mahowald M, Younger J, Pack AI. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007 Jun;30(6):711-9. doi: 10.1093/sleep/30.6.711.
Related trials for Sleep Apnea, Obstructive
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Faith S Luyster, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-oriented intervention, Patient-oriented intervention and Continuous positive airway pressure (CPAP) in people with Sleep Apnea, Obstructive, run by University of Pittsburgh 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 8 inclusion and 8 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 2 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Daytime Sleepiness (time frame: baseline and 3 months after CPAP initiation). 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 NCT01377584, which also lists 20 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 2 Oct 2017.